GLEN APSELOFF, M - Ohio Clinical Trials, Inc.GLEN APSELOFF, M.D., F.C.P. Ohio Clinical Trials, Inc. 1380 Edgehill Road Columbus, OH 43212 Office: (614) 754-1570 Fax: (614) 291-0817

GLEN APSELOFF, M.D., F.C.P. Ohio Clinical Trials, Inc.

1380 Edgehill Road

Columbus, OH 43212

Office: (614) 754-1570

Fax: (614) 291-0817

Email: [email protected]

PROFESSIONAL MASSACHUSETTS GENERAL HOSPITAL, Boston, MA

EXPERIENCE Applications Programmer/Analyst, Laboratory of Computer Science.

Computerized three hospital laboratories at Massachusetts General Hospital.

1981 Developed software to optimize dosing schedules based on individual drug half-

to life and peak/trough levels. Conducted research in quality control in an acute care

1982 laboratory.

1986 MOUNT CARMEL MEDICAL CENTER, Columbus, OH

to Resident Physician, Obstetrics and Gynecology. Completed rotations in

1987 obstetrics/gynecology, medical intensive care, emergency medicine, psychiatry,

general surgery, and radiology.

1987 SOUTHERN OHIO EMERGENCY PHYSICIANS, Clearwater, OH

Emergency medicine. Solo in-house physician.

1987 MASTER/MAY FAMILY PRACTICE, Columbus, OH

to Provided family practice patient care to low-income patients in a high-volume,

1988 inner-city clinic.

1993 AMERICAN COLLEGE OF CLINICAL PHARMACOLOGY

Instructor for the review course for Board Examinations.

1988 OHIO STATE UNIVERSITY COLLEGE OF MEDICINE, DEPARTMENT

OF PHARMACOLOGY

Postprofessional Researcher. Assisted in conducting phase I clinical trials.

to Learned basic science techniques, including methods for the separation,

identification, and quantification of compounds – HPLC, GC, MS. Conducted

basic science research, and presented results at scientific meetings and in

1989 print.

1989 Research Scientist. Participated in all aspects of laboratory research, including

studies of pharmacokinetics and drug metabolism/disposition. Conceptualized,

designed, and wrote basic science/clinical protocols and grants, performed small-

to animal surgeries, analyzed biological samples, obtained use patents, and presented

data in print and in conferences. Organized and presented lectures for medical

2005 students and graduate students, and wrote questions for examinations.

1993 Adjunct Asst./Assoc. Professor. Instructed medical and graduate students,

including presenting lectures, teaching tutorials (problem-solving sessions),

to providing individual instruction, and writing examination questions. Served

as coadvisor for graduate students, and reviewed their progress toward a degree.

2005 Supervised a Master's track in Clinical Pharmacology.

2005 Research Professor/Scientist. Conduct research. Instruct medical students, graduate

students, and Fellows. Serve on departmental committees (e.g., admissions

to committee for graduate school). Oversee Master’s track and Fellowship program

in clinical pharmacology. Serve as course director for Design of Clinical Trials I

2014 and II. Write exam questions and conduct oral exams.

2014 to Adjunct Professor (retired). Instruct medical students and graduate students. Assist

present colleagues with research.

1991 Associate Director of Clinical Pharmacology. Assisted in all aspects of phase

I clinical trials: served as coinvestigator or principal investigator in clinical

to trials, wrote consent forms, and negotiated budgets. Marketed our facilities

to potential pharmaceutical sponsors. Interviewed prospective employees.

1997 Negotiated protocols with the FDA.

1997 Director of Clinical Pharmacology. Implement and direct phase I clinical

trials. Serve as principal investigator in industry-sponsored studies.

Negotiate contracts with pharmaceutical sponsors. Manage overall operations

to of the clinical program: coordinate simultaneous clinical trials; hire, train,

manage, and evaluate physician employees; oversee maintenance of facilities;

create and update standard operating procedures; design and update web site;

2012 market the program to potential pharmaceutical sponsors.

2012 OHIO CLINICAL TRIALS, INC.

President and Principal Investigator. Transitioned the clinical research program

to from Ohio State University to Ohio Clinical Trials, Inc. Added 3000+ sq. ft. and

increased capacity from 39 to 55 beds. Added services of medical/other monitoring,

present project management, data management, biostatistics, and medical writing.

EDUCATION MASSACHUSETTS INSTITUTE OF TECHNOLOGY, Cambridge, MA

Bachelor of Science Degree in Mathematics, May, 1981. GPA: 4.7/5.0.

OHIO STATE UNIVERSITY COLLEGE OF MEDICINE, Columbus, OH

Doctor of Medicine Degree, June, 1986. Honors in Preventive Medicine

and Behavioral Sciences. Letter of Commendation in Internal Medicine.

CREDENTIALS Board Certified in Clinical Pharmacology, 1992-present.

State of Ohio Medical License, 1987-present.

AND Certified in Advanced Cardiac Life Support (expir. Feb. 2017).

Smoking Cessation Educator (American Lung Association).

AWARDS Excellence in Teaching Award, Ohio State University College of Medicine, 2007.

Inducted into Kent City Schools Hall of Fame, 2012.

MEMBERSHIP Fellow of the American College of Clinical Pharmacology, 1992-present.

Editorial Board of The Journal of Clinical Pharmacology, 1993-present.

Editorial Board of American Journal of Therapeutics, 1994-present.

Section Editor (Therapeutic Reviews) 2008-present.

Editorial Board of Clinical Pharmacology & Therapeutics, 2001-present.

Member of the Am. Soc. for Pharmacol. & Exper. Therap., 1994-present.

Member of the Am. Soc. for Clin. Pharmacol. and Therap., 1997-present.

Member of the Am. Assoc. of Pharmaceutical Scientists, 1997-present.

Member of Drug Information Association, 1998-present.

PUBLICATIONS

1. Matkovic, V., Apseloff, G., Shepard, D.R., Gerber, N.: Use of gallium to treat Paget’s

disease of bone: a pilot study. Lancet, 335: 72-75, 1990.

2. Apseloff, G., Shepard, D.R., Chambers, M.A., Nawoot, S., Mays, D.C., Gerber, N.:

Inhibition and induction of theophylline metabolism by 8-methoxypsoralen: in vivo study in

rats and humans. Drug Metab. Dispos., 18: 298-303, 1990.

3. Matkovic, V., Apseloff, G., Shepard, D., Gerber, N.: Hazards of gallium for Paget’s disease

of bone. Invited reply to a letter. Lancet, 335: 1099, 1990.

4. Matkovic, V., Apseloff, G., Shepard, D., Jelic, T., Gerber, N.: Effects of gallium nitrate upon

bone turnover and serum lipid levels in postmenopausal women. Curr. Therap. Res., 50:

247-254, 1991.

5. Matkovic, V., Balboa, A., Clinchot, D., Whitacre, C., Zwilling, B., Brown, D., Weisbrode,

S.E., Apseloff, G., Gerber, N.: Gallium prevents adjuvant arthritis in rats and interferes with

macrophage/T-cell function in the immune response. Curr. Therap. Res., 50: 255-267, 1991.

6. Apseloff, G., Hilligoss, D.M., Gardner, M.J., Henry, E.B., Inskeep, P.B., Gerber, N., Lazar,

J.D.: Induction of fluconazole metabolism by rifampin: in vivo study in humans. J. Clin.

Pharmacol., 31: 358-361, 1991.

7. Apseloff, G., Hilliard, J.B., Gerber, N., Mays, D.C.: Inhibition and induction of drug

metabolism by psoralens: Alterations in duration of sleep induced by hexobarbital and in

clearance of caffeine and hexobarbital in mice. Xenobiotica, 21: 1461-1471, 1991.

8. Apseloff, G., Girten, B., Walker, M., Shepard, D. R., Matkovic, V., Stern, L.S., Gerber, N.:

Aminohydroxybutane bisphosphonate prevents bone loss in a rat model of simulated

weightlessness. Curr. Therap. Res., 50: 794-803, 1991.

9. Apseloff, G., Girten, B., Gerber, N., Shepard, D., Matkovic, V.: The effect of gallium nitrate

upon bone loss in a rat model of simulated microgravity. Aviat. Space Environ. Med., 63:

27-31, 1992.

10. Whitacre, C., Apseloff, G., Cox, K., Matkovic, V., Jewell, S., Gerber, N.: Suppression of

experimental autoimmune encephalomyelitis by gallium nitrate. J. Neuroimmunol., 39: 175-

182, 1992.

11. Apseloff, G., Wilner, K.D., von Deutsch, D.A., Henry, E.B., Tremaine, L.M., Gerber, N. and

Lazar, J.D.: Sertaline does not alter steady-state concentrations or renal clearance of lithium

in healthy volunteers. J. Clin. Pharmacol., 32: 643-646, 1992.

12. Apseloff, G., Whitacre, C., Gerber, N.: Long-term effects of gallium nitrate in patients with

Paget’s disease of bone. J. Bone Miner. Res., 7: 1240-1241, 1992.

PUBLICATIONS (cont)

13. Apseloff, G., Girten, B., Walker, M., Shepard, D.R., Krecic, M.E., Stern L.S., Gerber, N.:

Aminohydroxybutane bisphosphonate and clenbuterol prevent bone changes and retard

muscle atrophy respectively in tail-suspended rats. J. Pharmacol. Exp. Ther., 227: 1071-

1078, 1993.

14. Gerber, N., Apseloff, G. Death from a morphine infusion during a sickle cell crisis. J.

Pediatr., 123: 322-325, 1993.

15. Apseloff, G., Girten, B., Weisbrode, S.E., Walker, M., Stern, L.S., Krecic, M.E., Gerber, N.:

Effects of aminohydroxybutane bisphosphonate on bone growth when administered after

hind-limb bone loss in tail-suspended rats. J. Pharmacol. Exp. Ther., 267: 515-521, 1993.

16. Gerber, N., Apseloff, G.: Pain relief during sickle cell crisis. Invited reply to letter. J.

Pediatr., 124: 162-163, 1994.

17. Stern, L.S., Matkovic, V., Weisbrode, S.E., Apseloff, G., Shepard, D.R., Mays, D.C., Gerber,

N. The effects of gallium nitrate on osteopenia induced by ovariectomy and a low-calcium

diet in rats. Bone and Miner., 25: 59-69, 1994.

18. Apseloff, G., Ashton, H.M., Friedman, H., Gerber, N.: The importance of measuring cotinine

levels in clinical trials. Clin. Pharmacol. Ther., 56:460-462, 1994.

19. Apseloff, G., Wilner, K.D., Gerber, N.: Effect of tenidap sodium on the pharmacodynamics

and plasma protein binding of warfarin in healthy volunteers. Brit. J. Clin. Pharmacol., 39:

29S-33S, 1995.

20. Apseloff, G., Wilner, K.D., Von Deutsch, D.A., Gerber, N.: Tenidap sodium decreases renal

clearance and increases steady-state concentrations of lithium in healthy volunteers. Br. J.

Clin. Pharmacol., 39: 25S-28S, 1995.

21. Mays, D.C., Pawluk, L.J., Apseloff, G., Davis, W.B., She, Z., Sagone, A.L., Gerber, N.:

Metabolism of phenytoin and covalent binding of reactive intermediates in activated human

neutrophils. Biochem. Pharmacol., 50: 367-380, 1995.

22. Orosz, C.G., Wakely, E., Sergese, S.D., VanBuskirk, A.M., Ferguson, R.M., Mullet, D.,

Apseloff, G., Gerber, N.: Prevention of murine cardiac allograft rejection with gallium

nitrate: Comparison with anti-CD4 mAb. Transplantation, 61: 783-791, 1996.

23. Apseloff, G., Swayne, J., Gerber, N.: Medical histories may be unreliable in screening

volunteers for clinical trials. Clin. Pharmacol. Ther., 60: 353-356, 1996.

24. Apseloff, G., Foulds, G., LaBoy-Goral., L., Kraut, E., Vincent, J.: Severe neutropenia caused

by recommended prophylactic doses of rifabutin. Lancet, 348: 685, 1996.

PUBLICATIONS (cont)

25. Apseloff, G., Foulds,G., LaBoy-Goral, L., Vincent, J.: Severe neutropenia and prophylactic

doses of rifabutin. Invited reply to a letter. Lancet, 348: 1593, 1996.

26. Apseloff, G., Wilner, K.D., Gerber, N., Tremaine, L.M.: Effect of sertraline on protein

binding of warfarin. Clin. Pharmacokinet., 32: 37-42, 1997.

27. Apseloff, G. Swayne, J., Gerber, N.: Reliability of screening procedures in identifying

subjects suitable for enrollment in clinical pharmacology studies. Invited reply to a letter.

Clin. Pharmacol. Ther., 62: 113-114, 1997.

28. Apseloff, G., Hackshaw, K.V., Whitacre, C., Weisbrode, S.E., Gerber, N.: Gallium nitrate

suppresses lupus in MRL/lpr mice. Arch. Pharmacol., 356: 517-525, 1997.

29. Apseloff, G., Foulds, G., LaBoy-Goral, L., Willavize, S., Vincent J. Comparison of

azithromycin and clarithromycin in their interactions with rifabutin in healthy volunteers. J.

Clin. Pharmacol., 38: 830-835, 1998.

30. Liston, T.E., Conklyn, M.J., Houser, J., Wilner, K.D., Johnson, A., Apseloff, G., Whitacre,

C., Showell, H.J.: Pharmacokinetics and pharmacodynamics of the leukotriene B4 receptor

antagonist CP-105,696 in man following single oral administration. Br. J. Clin. Pharmacol.,

45: 115-121, 1998.

31. Foulds, G., LaBoy-Goral, L., Wei, G.C.G., Apseloff, G.: The effect of azithromycin on the

pharmacokinetics of indinavir. J. Clin. Pharmacol., 39: 842-846, 1999.

32. Krecic-Shepard, M.E., Shepard, D.R., Mullet, D., Apseloff, G., Weissbrode, S.E., Gerber, N.:

Gallium nitrate suppresses the production of nitric oxide and liver damage in a murine model

of LPS-induced septic shock. Life Sci., 65: 1359-1371, 1999.

33. Apseloff, G.: Therapeutic uses of gallium nitrate--past, present, and future. Am. J. Therap., 6:

327-339, 1999.

34. Apseloff, G., Mullet, D., Wilner, K.D., Anziano, R.J., Tensfeldt, T.G., Pelletier, S.M.,

Gerber, N.: The effects of ziprasidone on steady-state lithium levels and renal clearance of

lithium. Br. J. Clin. Pharmacol., 49(S1): 61-64, 2000.

35. Wilner, K.D., Demattos, S.B., Anziano, R.J., Apseloff, G., Gerber, N.: Ziprasidone and the

activity of cytochrome P450 2D6 in healthy extensive metabolizers. Br. J. Clin. Pharmacol.,

49(S1): 43-47, 2000.

36. Miceli, J.J., Wilner, K.D., Hansen, R.A., Johnson, A.C., Apseloff, G., Gerber, N.: Single-

and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy

male volunteers. Br. J. Clin. Pharmacol., 49(S1): 5-13, 2000.

PUBLICATIONS (cont)

37. Apseloff, G., Xiaohui, B., LaBoy-Goral, L., Friedman, H., Shah, A.: Practical considerations

regarding the influence of the menstrual cycle on leukocyte parameters in clinical trials. Am.

J. Therap., 7: 297-302, 2000.

38. Shah, A.K., LaBoy-Goral, L., Scott, N., Morse, T., Apseloff, G.: Pharmacokinetics and safety

of oral eletriptan during different phases of the menstrual cycle in healthy volunteers. J. Clin.

Pharmacol., 41: 1339-1344, 2001.

39. Gerber, N., Apseloff, G.: Fatality following an injection of Bicillin® into the tonsillar fossa

during an adenotonsillectomy. Otolaryngol. Head Neck Surg., 126: 321-2, 2002.

40. Tassava, R.A., Mendenhall, L., Apseloff, G., Gerber, N.: Gallium nitrate: effects on cartilage

during limb regeneration in the axolotl, Ambystoma mexicanum. J. Exp. Zool., 293: 384-94,

2002.

41. Apseloff, G.: HIV testing in early clinical trials – who should decide whether it is warranted?

J. Clin. Pharmacol., 42: 601-604, 2002.

42. Apseloff, G.: Severe neutropenia among healthy volunteers given rifabutin in clinical trials.

Clin. Pharmacol. Ther., 74: 591-592, 2003.

43. Stoner, G.D., Sardo, D., Apseloff, G., Mullet, D., Wargo, W., Pound, V., Singh, A., Sanders,

J., Aziz, R., Casto, B., Sun X.: Pharmacokinetics of anthocyanins and ellagic acid in healthy

volunteers fed freeze-dried black raspberries daily for 7 days. J. Clin. Pharmacol., 45: 1153-

1164, 2005.

44. Shah, A., DeGroot, T., Apseloff, G.: Pharmacokinetic evaluation and safety profile of a 15-

minute versus 30-second infusion of palonosetron in healthy subjects. J. Clin. Pharmacol.,

46: 1-7, 2006.

45. Tishler, C.L., Apseloff, G., Bartholomae, S., Reiss, N.S., Rhodes, A.R., Singh, A.: Are

normal healthy research volunteers psychologically healthy? A pilot investigation. Exp. Clin.

Psychopharmacol., 15: 539-545, 2007.

46. Cotreau, M.M., Chennathukuzhi, V.M., Harris, H.A., Han, L., Hatstat, E., Zakaria, M.,

Apseloff, G., Strahs, A.L., Crabtree, J.S., Winneker, R.C., Jelinsky, S.A.: A study of 17-

estradiol-regulated genes in the vagina of postmenopausal women with vaginal atrophy.

Maturitas, 58: 366-376, 2007.

47. Johnson, B.M., Adams, L.M., Zhang, K., Gainer, S.D., Kirby, L.C., Blum, R.A., Apseloff,

G., Morrison, R.A., Schutz, R.A., Lebowitz, P.F.: Ketoconazole and rifampin significantly

affect the pharmacokinetics, but not the safety or QTc interval, of casopitant, a neurokinin-1

receptor antagonist. J. Clin. Pharmacol., 50: 951-959, 2010.

PUBLICATIONS (cont)

48. Kitzmiller, J.P., Groen, D.K., Ardeleanu, M., Apseloff, G.: A novel minimally-invasive

method for eliciting incisional pain in healthy adults. J. Anaesth. Clin. Pharmacol. 26: 54-58,

2010.

49. Groen, D.K., Harris, S.C., Colucci, S., Apseloff, G.: Serum transaminase levels should be

measured immediately prior to dosing in early phase I clinical trials. J Clin Pharmacol. 51:

252-255, 2011.

50. Kapil, R.P., Cipriano, A., Friedman, K., Michels, G., Shet, M.S., Colucci, S.V., Apseloff, G.,

Kitzmiller, J., Harris, S.C.: Once-weekly transdermal buprenorphine application results in

sustained and consistent steady-state plasma levels. J. Pain Symptom Manag. 46: 65-75,

2013.

51. Apseloff, G., Onel, E., Patou, G.: Time to onset of analgesia following local infiltration of

liposome bupivacaine in healthy volunteers: a randomized, single-blind, sequential cohort,

crossover study, Int. J. Clin. Pharmacol. Therap. 51: 367-73, 2013.

52. Apseloff, G., Kitzmiller, J.P., Tishler, C.L.: Credibility and comprehension of healthy

volunteers in lengthy inpatient drug studies. Am. J. Therap. 20: 257-60, 2013.

53. Perrino, P.J., Colluci, S.V., Apseloff, G., Harris, S.C.: Pharmacokinetics, tolerability, and

safety of intranasal administration of reformulated OxyContin® tablets compared with

original OxyContin® tablets in healthy adults. Clin. Drug Invest. epub ahead of print, DOI

10.1007/s40261-013-0085-x, 2013.

54. Sardo, C.L., Kitzmiller, J.P., Apseloff, G., Harris, R.B., Roe, D.J., Stoner, G.D., Jacobs, E.T.:

An open-label, randomized crossover trial of lyophilized black raspberries on postprandial

inflammation in older, overweight males: a pilot study, Am. J. Therap. 2013 (in press).

55. Apseloff, G.: Reliability of professional volunteers recruited for clinical trials. J. Clin.

Pharmacol. 54: 616-18, 2014.

56. Nunez, D.J., Bush, M.A., Collins, D.A., McMullen, S.L., Gillmor, D., Apseloff, G.,

Atiee, G., Corsino, L., Morrow, L., Feldman, P.L. Gut hormone pharmacology of a novel

gpr119 agonist (gsk1292263), metformin, and sitagliptin in type 2 diabetes mellitus: results

from two randomized studies. PLOS ONE 9: e92494, 2014.

57. Kitzmiller, J.P., Phelps, M.A., Neidecker, M.V., Apseloff, G. Establishing a clinical

pharmacology fellowship program for physicians, pharmacists, and pharmacologists: a newly

accredited interdisciplinary training program at the Ohio State University. Advances Med.

Ed. Practice. 5: 1-6, 2014.

http://www.ncbi.nlm.nih.gov/pubmed/20354235

http://www.ncbi.nlm.nih.gov/pubmed/20354235

ABSTRACTS

1. Shepard, D., Apseloff, G., Balboa, A., Mays, D., Gerber, N., Matkovic, V.: The effect of

gallium nitrate on Paget’s disease of bone. Pharmacologist, 31: 161, 1989.

2. Matkovic, V., Apseloff, G., Mays, D., Balboa, A., Shepard, D., Gerber, N.: The effect of

gallium nitrate on bone resorption indices in humans and bone mineral density in

osteoporotic rat. Steenbock Symposium, 1989.

3. Matkovic, V., Apseloff, G., Mays, D., Balboa, A., Shepard, D., Gerber, N.: Plasma calcium

and alkaline phosphatase activity in postmenopausal women treated with gallium nitrate.

ASBMR/ICCRH First Joint Meeting, 1989.

4. Apseloff, G., Shepard, D., Chambers, M., Nawoot, S., Gerber, N., Mays, D.: Inhibition of

theophylline metabolism by 8-methoxypsoralen: in vivo study in humans. Europ. J. Clin.

Pharmacol., 36: 263, 1989.

5. Pawluk, L., Mays, D., She, Z., Davis, W., Apseloff, G., Gerber, N.: Metabolism of phenytoin

by activated human neutrophils. Europ. J. Clin. Pharmacol., 36: 251, 1989.

6. Apseloff, G., Chambers, M., Shepard, D., Nawoot, S., Mays, D., Gerber, N.: Inhibition and

induction of theophylline metabolism by 8-methoxypsoralen with resulting changes in its

renal excretion: in vivo study in the rat. FASEB J., 3: 2948, 1989.

7. Matkovic, V., Apseloff, G., Balboa, A., Shepard, D., Pawluk, L., Mays, D., Gerber, N.:

Gallium nitrate inhibits bone resorption in postmenopausal women. Pharmacologist, 31:

160, 1989.

8. Apseloff, G., Shepard, D.R., Balboa, A., Gerber, N., Mays, D.C., Weisbrode, S.E., Stern,

L.S., Matkovic, V.: The effect of gallium nitrate on osteopenia in rats and postmenopausal

women. Europ. J. Pharmacol., 183: 1760-1761, 1990.

9. Apseloff, G., Mays, D., Pacula, C., Gerber, N.: Isolation of 5-methoxypsoralen from Earl

Grey Tea. FASEB J., 4: A516, 1990.

10. Mays, D.C., Balboa, A., Pawluk, L.J., Nawoot, S., Apseloff, G., Gerber, N.: The rat is a

useful model to study azidothymidine pharmacokinetics. Clin. Pharm. Ther., 147: 157, 1990.

11. Wilner, K.D., Lazar, J.D., Apseloff, G., Gerber, N: The effects of sertraline on the

pharmacodynamics of warfarin in healthy volunteers. 5th World Congress of Biological

Sciences, 1991.

12. Wilner, K.D., Lazar, J.D., von Deutsch, D.A., Apseloff, G., Gerber, N.: The effects of

sertraline on steady-state lithium levels and renal clearance of lithium. 5th World Congress

of Biological Sciences, 1991.

ABSTRACTS (cont)

13. Matkovic, V., Gerber, N., Brown, D., Apseloff, G., Zwilling, B.S.: Differential effect of

gallium on MHC class II expression by murine macrophages. FASEB J., 5: A1206, 1991.

14. Stern, L.S., Matkovic, V., Gerber, N., Apseloff, G., Weisbrode, S.: Effects of gallium nitrate

on osteopenia in rats. Bone & Min. Res., 6(1): S216, 1991.

15. Apseloff, G., Girten, B., Weisbrode, S.E. Walker, M., Stern., L.S., Krecic, M.E.: Effects of

Aminohydroxybutane bisphosphonate on bone in tail-suspended rats, FASEB J., 7: A150,

1993.

16. Apseloff, G., Whitacre, C., Weisbrode, S.E., Krecic, M.E., Shepard, D.R., Hackshaw, K.,

Gerber, N.: Gallium suppresses lupus in MRL/lpr mice. ASCEPT, 1993.

17. Gerber, N., Apseloff, G.: Immunomodulatory effects of gallium nitrate. Future Trends in

Chemotherapy, Interdisciplinary World Congress on Antimicrobial and Anticancer Drugs,

Palexpo Geneva, Switzerland, 1994.

18. Apseloff, G., Hackshaw, K., Whitacre, C., Weisbrode, S.E., Gerber, N.: Gallium suppresses

lupus in MRL/lpr mice. FASEB J., 8: A645, 1994.

19. Koudriakova, T., Choe, S., Gerber, N., G. Apseloff: Dose-dependent elimination of 5-

methoxypsoralen: In vivo study in rats. FASEB J., 8: A99, 1994.

20. Krecic, M.E., Mullet, D., Shepard, D.R., Apseloff, G., Weisbrode, S.E., Zaveri, N., Gerber,

N.: Gallium nitrate attenuates lipopolysaccharide-induced hepatitis in Balb/c mice. ASCEPT,

1994.

21. Krecic, M.E., Shepard, D.R., Apseloff, G., Weisbrode, S.E., Gerber, N.: Gallium nitrate

attenuates lipopolysaccharide-induced hepatitis in Balb/c mice. FASEB J., 9: A944, 1995.

22. Collins, J., Choe, S., Spetie, D., Mullet, D., Koudriakova, T., Gerber, N., Apseloff, G.: Lack

of effect of cigarette smoking on the pharmacokinetics of rifabutin. FASEB J., 9: A688,

1995.

23. Koudriakova, T., Spetie, D., Utkin, I., Apseloff, G., Gerber, N.: Pharmacokinetics of

rifabutin in the rat. FASEB J., 9: A688, 1995.

24. Krecic, M.E., Mullet, D., Shepard, D.R., Apseloff, G., Weisbrode, S.E., Zaveri, N., Gerber,

N.: Gallium nitrate inhibits nitric oxide in vitro and attenuates lipopolysaccharide-induced

hepatitis in Balb/c mice in vivo. Proceedings of 6th INWIN, Geneva, Switzerland, 1995.

25. Weisbrode, S.E., Apseloff, G., Hackshaw, K.V., Whitacre, C., Gerber, N.: Gallium nitrate

reduces lesions in MRL/lpr mice. 13th European Congress on Veterinary Pathology,

Edinburgh, Scotland, 1995.

ABSTRACTS (cont)

26. Weisbrode, S.E., Apseloff, G., Hackshaw, K.V., Whitacre, C., Gerber, N.: Gallium nitrate

ameliorates spontaneous lesions in MRL/lpr mice but induces osteosclerosis. 46th Annual

Meeting, Bone & Joint Specialty Groups, Atlanta, GA, 1995.

27. Apseloff, G., LeRoy, B., Weisbrode, S.E., Collins, J., Gerber, N., Mullet, D.: Gallium nitrate

ameliorates asthma in B6D2F1/J mice. FASEB J., 10: A441, 1996.

28. Teng, R., Apseloff, G., Vincent, J., Pelletier, S.M., Willavize, S.A., Friedman, H.L.: Effect of

trovafloxacin (CP-99,219) on the pharmacokinetics and pharmacodynamics of warfarin in

healthy male subjects. 36th ICAAC, 1996.

29. Vincent, J., Foulds, G., Apseloff, G., Laboy-Goral, L., Gerber, N.: Interaction of rifabutin

(RIF) with the macrolides azithromycin (AZM) and clarithromycin (CLA). 36th ICAAC,

1996.

30. Foulds, G., LaBoy-Goral, L., Wei, G., Apseloff, G.: The effect of azithromycin (AZM) on the

pharmacokinetics of indinavir (IND). Fourth International Conference on the Macrolides,

Azalides, Streptogramins & Ketolides. Barcelona, Spain. Abstract #5.04, p. 53, 1998.

31. Vincent, J., Gardner, M.J., Apseloff, G., Baris, B., Willavize, S., Friedman, H.L.: Cimetidine

inhibits renal elimination of dofetilide without altering QTc activity on multiple dosing in

healthy subjects. Clin. Pharmacol. Therap., 63: 210, 1998.

32. Vincent, J., Agin, M., LaBoy-Goral, L., Hunt, T., Carlson, J., Apseloff, G., Kuye, O.: The

effect of dosing with food and bedtime dosing on the incidence of dizziness with

trovafloxacin in young, healthy, female subjects. 38th ICAAC, 1998.

33. Shah, A.K., Friedman, D.L., Morse, T.M., LaBoy-Goral, L., Hinkel, C.A., Silber, M.,

Apseloff, G., Friedman, H.L.: Evaluation of methods for rapid screening of CYP2D6 status

using dextromethorphan as a probe in normal, healthy subjects. aaps PharmSci Suppl., 1(1):

S-32, 1998.

34. Apseloff, G., Vashi, V., Kuye, O.: Lack of a pharmacokinetic interaction between amlodipine

and atorvastatin at steady-state. aaps PharmSci Suppl., 1(1): S-623, 1998.

35. Sardo, C., Sun, X, Apseloff, G., Mullet, D., Wargo, W., Pound, V., Singh, A., Sanders, J.,

Aziz, R., Casto, B., Stoner, G.: Pharmacokinetics of anthocyanins and ellagic acid in healthy

subjects consuming black raspberries. Cancer Epidemiology Biomarkers and Prevention,

13(11): Part 2, 1882S, 2004.

36. Jones, T., Apseloff, G., Carter, E.: Comparative pharmacokinetics of topical tacrolimus

cream 0.03% with cream 0.01% and ointment 0.03% in adults and with ointment 0.03% in

pediatric patients with atopic dermatitis. J. Am. Acad. Derm. 52(3): 68, 2005.

ABSTRACTS (cont)

37. Singh, A., Apseloff, G., Colucci, R., Harris S.C., Vashi, V.: A crossover study with single &

divided-dose oral naloxone (NX), oral pentazocine/NX, & intravenous NX in healthy

subjects. Clin. Pharmacol. Therap., 77(2): P85, 2005.

38. Apseloff, G., Singh, A., Vause E., Richards P.: Determination of the optimal configuration of

ALGRX 3268 for induction of local analgesia prior to venipuncture in the antecubital fossa.

J. Pain, 6(3): S50, 2005.

39. Apseloff, G., Vause E., Singh, A., Sykes, D.: Treatment with ALGRX 3268 does not result in

detectable lidocaine levels in healthy adults. J. Pain, 6(3): S49, 2005.

40. Apseloff, G., Gallagher, S., Shah, A.: Pharmacokinetics (PK) and safety evaluation of

palonosetron (PALO) administered as a 15-minute infusion versus a 30-second infusion in

healthy subjects. Support. Care Cancer, 13: 412-413, 2005.

41. Strout, V., Casey, L., Nardone, L., Curtis, K., Adaelu, J., D’Alia, G., Lazar, J., Singh, A.,

Apseloff, G.: ETI-204, a monoclonal antibody with high affinity against protective antigen

produced by anthrax, is well tolerated and safe when administered alone or with

ciprofloxacin in healthy volunteers. 46th ICAAC Abstract Book, p. 41, 2006.

42. Kitzmiller, J., Groen, D., Apseloff, G.: An analysis of subjects in clinical trials who, after

dosing, report predose adverse events and abnormalities in their past medical histories. Clin.

Pharmacol. Therap., 85: S19, 2009.

43. Singh, A., Apseloff, G., Groen, D., Tishler, C., Bartholomae, S.: Characteristics and attitudes

of participants in a phase I clinical trial. Clin. Pharmacol. Therap., 85: S79, 2009.

44. Groen, D.K., Harris, S.C., Apseloff, G., Colucci, S.: Benefits of measuring liver function

tests immediately prior to dosing in early phase I clinical trials. Clin. Pharmacol. Therap., 85:

S19, 2009.

45. Groen, D.K., Harris, S.C., Singh, A., Apseloff, G.: Implications of nonsustained ventricular

tachycardia (NSVT) in healthy subjects in clinical trials. Clin. Pharmacol. Therap., 89: S72,

2011.

46. Kitzmiller, J.P., Groen, D.K., Singh, A., Savage, L., Cipriano, A., Friedman, K., Harris,

S.C., Apseloff, G. Multiple-application pharmacokinetics and adhesion analyses of

a buprenorphine transdermal system. J. Pain 2011; 12(4): P58.

47. Kitzmiller, J.P., Cirpili, E.M., Apseloff, G. A comparison of three methods for eliciting

thermal pain in healthy males. J. Pain 2012; 13(4S), S24.

48. Nunez, D., Bush, B., Collins, D., McMullen, S., Apseloff, G., Atiee, G., Carsina, L., Morrow,

L., Feldman, P. Novel effects on lipids of GSK1292263, a GPR119 agonist, in type 2

diabetics. Diabetes 2012; 61 (suppl 1):A279-280.

ABSTRACTS (cont)

49. Colucci, S., Harris, S., Perrino, P.J., Apseloff, G. Safety, tolerability, and pharmacokinetics

of crushed intranasal oxycodone tamper-resistant tablets and OxyContin® in healthy adults.

Poster presented at: College on Problems of Drug Dependence (CPDD) 74th Annual

Meeting; June 9-14, 2012; Palm Springs, CA.

OTHER PUBLICATIONS

Apseloff, G. Atlantic Puffin, Machias Seal Island. Filler photograph, N. Engl. J. Med. 365(23):

2219, 2011.

News & Views, Dedicated Member, Clin. Pharmacol. Therap., 90:759-60, 2011.

Apseloff, G. Grizzly Bear, Katmai National Park, Alaska. Filler photograph, N. Engl. J. Med.

366(16): 1543, 2012.

Apseloff, G. Brown Pelicans, Key Largo, Florida. Filler photograph, N. Engl. J. Med. 367(21):

2062, 2012.

Apseloff, G. Scarlet Macaw, Osa Peninsula, Costa Rica. Filler photograph, N. Engl. J. Med.

368(17): 1651, 2013.

Apseloff, G. Backyard Birds: Looking Through the Glass, Ohio Distinctive Publishing, 2013.

SELECTED GRANTS FROM INDUSTRIAL SPONSORS

(Performed initially as an investigator at the Ohio State University [through December 2011] and

then at Ohio Clinical Trials, Inc.)

1. Phase I Study to Determine the Difference Between Urine Concentrations of CP-73-850 at

Steady State and the Urine Solubility of CP-73,850 in Healthy Volunteers (078-007-501),

1988. Pfizer, Inc. Co-Investigator.

2. Disopyramide Bioavailability Pilot Study Protocol Kinaform, 1988. Chartwell Technologies

Inc. Co-Investigator.

3. Pilot Study to Assess the Reproducibility of Steady State Serum Lithium Concentrations and

Renal Clearance of Lithium in Healthy Volunteers (050-015-501), 1988. Pfizer, Inc. Co-

Investigator.

4. Phase I Study of the Effect of Concomitant Antacid Administration on the Absorption of

Azithromycin (066-015-501), 1988. Pfizer, Inc. Co-Investigator.

5. A Multiple Dose, Double-Blind, Placebo-Controlled Study of the Safety, Toleration and

Pharmacokinetics of CP-72,467 in Healthy Male Volunteers (118-001-501), 1988. Pfizer,


6. Phase I Study to Assess the Potential of Amlodipine to Alter the Pharmacodynamics of

Warfarin (053-011-501), 1988. Pfizer, Inc. Co-Investigator.

7. Phase I Study to Assess the Potential of Sertraline to Alter Steady State Serum Lithium

Levels and Renal Clearance of Lithium in Healthy Volunteers (050-017-501), 1988. Pfizer,


8. Phase I Study of the Effect of Concomitant Cimetidine Administration on the Absorption of

Azithromycin (066-016-501), 1988. Pfizer, Inc. Co-Investigator.

9. Evaluation of the Safety, Clinical Activity, Toleration and Pharmacokinetics of CP-80,794. A

Single Escalating Dose Study in Normotensive Healthy Volunteers (120-001-501), 1988.

Pfizer, Inc. Co-Investigator.

10. A Phase I Study in Normal Male Volunteers to Assess the Safety, Toleration and

Pharmacokinetics of CP-72,133-2 (110-001-501), 1988-1989. Pfizer, Inc. Co-Investigator.

11. An Ultrasound Study of Ovarian Cyst Activity Comparing CTR-04 and CTR-05 Versus a

Concurrent Untreated Control (013-010), 1989 - 1990. Organon. Principal Investigator.

12. Phase I Study of the Safety, Toleration, and Bioavailability of Two Topical Piroxicam

Formulations in Healthy Volunteers (020-001-501), 1989. Pfizer, Inc. Co-Investigator.

SELECTED GRANTS FROM INDUSTRIAL SPONSORS (cont)

13. CGS-13492A Single-Oral-Dose Safety Study in Volunteers, Protocol 01, Version 2, 1989.

Ciba-Geigy. Co-Investigator.

14. Phase I Study of the Effect of Concomitant Rifampin Therapy on the Disposition of

Fluconazole (056-008-501), 1989. Pfizer, Inc. Co-Investigator.

15. Test of the Absorption of Adria Magnesium Lactate Tablets (114002-000), 1989. Adria

Laboratories. Co-Investigator.

16. Phase I, Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and

Pharmacokinetics of CP-80,794 in Normotensive Male Volunteers (120-003-501), 1989.


17. Phase I Study to Assess the Safety, Toleration and Bioavailability of Topically Applied CP-

70,490-09 (124-002-501), 1989. Pfizer, Inc. Co-Investigator.

18. A Bioavailability Study of Three Formulations of CP-72,133 (110-003-501), 1989. Pfizer,


19. Phase I Study to Assess the Potential of Tenidap Sodium to Alter Steady State Serum

Lithium Levels and Renal Clearance of Lithium in Healthy Volunteers (064-017-501),


20. Phase I Study to Assess the Potential of Tenidap Sodium to Alter the Pharmacodynamics and

Plasma Protein Binding of Warfarin in Healthy Volunteers (064-018-501), 1989. Pfizer, Inc.

Co-Investigator.

21. Single Dose Pharmacokinetic and Bioavailability Study of Toremifene in Postmenopausal

Healthy Volunteers (092016-000), 1989 - 1991. Adria Laboratories. Co-Investigator.

22. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and

Pharmacokinetics of Oral CP-72,133 in Normal Male Volunteers (110-002-501), 1989.


23. Single Oral Dose Safety Study of CGS-13429A in Volunteers (amended), 1989. Ciba-Geigy.

Co-Investigator.

24. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and

Pharmacokinetics of Topically Applied CP-70,490-09 in Normal Male Volunteers (120-004-

501), 1989. Pfizer, Inc. Co-Investigator.

25. Relative Bioavailability and Dose Proportionality of CGS-13429A Following Single Doses

of 4.0 mg Oral Buffered Solution, Two 2.0 mg Tablets and 4.0 mg Duodenal Infusion in the

Fasted State and Two 20.0 mg Tablets Non-Fasted in Healthy Volunteers (Protocol 02),

1989. Ciba-Geigy. Co-Investigator.


26. Phase I Study to Assess the Potential of Sertraline to Alter the Pharmacodynamics and

Plasma Protein Binding of Warfarin in Healthy Male Volunteers (050-018-501), 1989.


27. Open Label Crossover Study of the Uricosuric Activity of Single Doses of Tenidap Sodium

(CP-66,248-2) Compared to Probenecid (064-025-501), 1989. Pfizer, Inc. Co-Investigator.


Pharmacokinetics of Oral CP-72,133 in Normal Male Volunteers (110-002-501).

Rechallenge. 1989. Pfizer, Inc. Co-Investigator.

29. Phase I Study of the Effect of Concomitant Antacid Administration on the Absorption of

Amlodipine (053-012-501), 1990. Pfizer, Inc. Co-Investigator.

30. Single Dose Study of CP-86,325-2 in Normal Healthy Male Volunteers (127-001-501), 1990.


31. Multiple Oral Dose Safety Study of CGS-15873A in Healthy Normal Male Volunteers (06),


32. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration, and

Pharmacokinetics of CP-88,059-1 Following Escalating Single Oral Doses in Healthy Male

Volunteers (128-001-501), 1990. Pfizer, Inc. (Section 1). Co-Investigator.


Pharmacokinetics of Oral CP-86,325-2 in Normal Male Volunteers (127-002-501), 1990.



Pharmacokinetics of Oral CP-88,059-1 in Normal Male Volunteers (128-002-501), 1990.


35. Multiple Oral Dose Safety Study of CGS-18102A in Healthy Normal Male Volunteers (02),


36. A Continued Assessment of the Safety, Tolerance, and Pharmacokinetics of Single

Intravenous Doses of ADR-851 Compared to Placebo in Normal Healthy Male Volunteers

(117003-000), 1990. Adria Laboratories. Principal Investigator.

37. Double-Blind, Multiple Dose, Dose Escalating Safety Study of Intravenous RG 12915 in

Normal Volunteers, 1990. Rorer Central Research. Principal Investigator.


Pharmacokinetics of Oral CP-88,059-1 Titrated from 20 Mg BID to Either 60 Mg BID or 80

Mg BID in Normal Male Volunteers (128-005-501), 1991. Pfizer, Inc. Co-Investigator.


39. Phase I Double-Blind Evaluation of the Biological Effects and Safety of Multiple Doses of

CP-74,639 in Normal Subjects (090-003-501), 1991. Pfizer, Inc. Co-Investigator.

40. Phase I Crossover Study to Compare the Uricosuric Activity of a Single Dose of Sertraline

with that of Probenecid (050-023-501), 1991. Pfizer, Inc. Co-Investigator.

41. Phase I Double-Blind Evaluation, Placebo-Controlled Evaluation of the Safety, Toleration

and Pharmacokinetics of CP-108,671 Following Escalating Single Oral Doses in

Normotensive Male Volunteers (147-001-501), 1991. Pfizer, Inc. Co-Investigator.

42. Phase I Study to Determine the Levels of Tenidap Excreted in Breast Milk Compared with

the Plasma Levels of Tenidap in Normal Healthy Nursing Women (064-020-501), 1992.



Pharmacokinetics of Oral CP-86,325-2 at Doses of 50 to 200 mg/day in Normal Male

Volunteers (127-003-501), 1992. Pfizer, Inc. Principal Investigator.

44. Phase I Study to Examine the Metabolism and Excretion of 14C-Tenidap in Patients with

Biliary T-Tube Drainage (064-047-504), 1992. Pfizer, Inc. Principal Investigator.

45. Phase I Multiple Dose, Single-Blind Study to Assess the Effect of Tenidap on Platelet

Aggregation and Serotonin Release in Normal, Healthy Male Volunteers Ex Vivo (064-050-

504), 1992. Pfizer, Inc. Principal Investigator.

46. Phase I Single Dose, Double-Blind, Placebo-Controlled, Study Comparing the Safety and

Pharmacokinetics of Oral CP-86,325 to its Metabolite, CP-95,637 in Normal Male


47. Double-Blind Evaluation of the Safety and Pharmacokinetics of Single Ascending

Intravenous Doses of FK-037 (RWJ 45914-144) in Normal Subjects (M92-001), 1992. R.W.

Johnson. Principal Investigator.

48. Phase I Study of the Pharmacokinetics and Tolerability of Escalating Single Oral Doses of

SC-49483 in HIV-1(+) Volunteers with >300 CD4+ Cells/mm3 (NQ3-92-02-101), 1992.

G.D. Searle. Principal Investigator.

49. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration and

Pharmacokinetics of CP-105,696 Following Escalating Single Oral Doses in Normal Male



Pharmacokinetics of Oral CP-88,059-1 Under Non-Fasting Conditions in Normal Male



51. A Pilot Study to Assess the Oral Absorption Profile of Azithromycin in Ileostomy Patients

(066-049-501), 1992. Pfizer, Inc. Principal Investigator.

52. A Double-Blind, Randomized, Placebo Controlled, Dose Escalating, Crossover Study to

Evaluate Safety, Tolerability and Delivery Rates of Sandostatin® via Iontophoresis in

Healthy Male Volunteers (Z101), 1993. Sandoz Pharmaceuticals Corporation. Principal

Investigator.

53. Phase I Multiple Dose Double-Blind, Placebo-Controlled Evaluation of the Safety,

Toleration and Pharmacokinetics of CP-105,696 in Normal Male Volunteers (158-002-501).

1993. Pfizer, Inc. Principal Investigator.

54. An Observer-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Cimetidine on

the Pharmacokinetics and Pharmacodynamics of Dofetilide After Multiple Dosing (115-004-


55. An Open-Label, Single Dose, Crossover Study in Adult, Male Volunteers to Evaluate the

Effect of Food on Bioavailability of SDZWAG994 (P103), 1993. Sandoz Pharmaceuticals

Corporation. Principal Investigator.

56. Phase I Double Blind, Placebo Controlled, Study of the Safety, Toleration and

Pharmacokinetics of CP-114,271 When Administered as Escalating Single Doses to

Moderately Obese Volunteers (151-001-501), 1993. Pfizer, Inc. Principal Investigator.

57. A Two-Phase, Double-Blind, Placebo Controlled, Study in Adult Male Volunteers to

Evaluate the Interaction of Digoxin and SDZ WAG 994 (P109), 1993. Sandoz

Pharmaceuticals Incorporation. Principal Investigator.


Pharmacokinetics of Oral CP-88,059-1 Under Non-Fasting Conditions in Normal Male


59. A Multiple-Dose Evaluation of the Contribution of the Antihistamine Component of Regular

Dristan® Nasal Spray to the Symptomatic Relief of Nasal Congestion Associated with Upper

Respiratory Tract Infections (WM-600), 1993-1995. Whitehall/Kendle Research Associates.

Co-Investigator.

60. Phase I, Double Blind, Placebo Controlled, Study of the Safety, Toleration, Pharmacokinetics

and Pharmacodynamics of CP-114,271 When Administered as Escalating Multiple Doses to

Moderately Obese Volunteers (151-002-501), 1993. Pfizer, Inc. Principal Investigator.

61. Phase I Open Pilot Study to Compare the Pharmacokinetics of a Single 80 mg Oral Dose of

CP-88,059-1 Administered as Four 20 mg Capsules and One 80 mg Capsule to Normal,

Healthy Male Volunteers (128-019-501), 1993. Pfizer, Inc. Principal Investigator.


62. An Open Label Study of OG 37-325 in Stable Renal Transplant Patients to Evaluate the

effect of Concomitant Administration of a Single Dose of Erythromycin Ethylsuccinate

(EES) on the Pharmacokinetic Profile of OG 37-325 (P335), 1994. Sandoz Pharmaceuticals

Incorporation. Principal Investigator.

63. Experiments Involving Endotoxin-Mediated Hepatitis and Endotoxic Shock in Mice and

other Species, 1994. Ben Venue Laboratories. Co-Investigator.

64. An Open-Label Study in Healthy Volunteers to Evaluate the Absorption of SDZ WAG 994

from the Small and Large Intestine (P121), 1994. Sandoz Pharmaceuticals Incorporation.

Principal Investigator.

65. Phase I Double-Blind, Placebo Controlled, Evaluation of Safety, Toleration, and

Pharmacokinetics of CJ-11,802 Following Escalating Single Oral Doses in Healthy Male


66. Phase I Comparative Study of the Clinical Pharmacology of Azithromycin High Dosage

Strength Tablets After Fed and Fasted States in HIV-Infected Male Subjects (066-061-501),


67. Phase I Open Study to Assess the Potential of Ziprasidone to Alter the Renal Clearance of

Lithium and Steady-State Serum Lithium Levels in Normal, Healthy Male Volunteers (128-

025-501), 1994. Pfizer, Inc. Co-Investigator.

68. Phase I, Double-Blind, Placebo-Controlled, Crossover Evaluation of the Effects of CJ-11,974

on the Hypoxic Ventilatory Drive and the Perception of Dyspnea in Healthy Male Subjects

(167-005-4005), 1994. Pfizer, Inc. Co-Investigator.

69. Open Study Performed in a Parallel Group Design to Investigate the Effect of Age on the

Pharmacokinetics of Monatepil in 15 Elderly and 15 Young Volunteers Matched for Body

Surface (DA285), 1994-1995. LAB. Co-Investigator.

70. Phase I Double-Blind, Parallel, Placebo Controlled Pilot Study to Assess the Safety,

Toleration and Pharmacokinetics of Oral Sertraline Administered as a Single Dose and Over

a Defined Period of Time to Normal, Healthy Male Volunteers (050-031-501), 1995. Pfizer,

Inc. Principal Investigator.

71. Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

of the Efficacy and Safety of Six Weeks Treatment with Oral CJ-11,974 in Adults with Mild

to Moderate Asthma (167-102-4005), 1995. Pfizer, Inc. Co-Investigator.

72. Phase I, Open Study to Assess the Potential of Zopolrestat to Alter the Pharmacodynamics

and Plasma Protein Binding of Warfarin in Normal, Healthy Male Volunteers (078-014-501),



73. A Placebo-Controlled Study to Compare the Gastrointestinal Effects of Different

Formulations of Azithromycin When Given as a Single Oral Dose to Parallel Groups of

Healthy Volunteers (066-072), 1995. Pfizer, Inc. Co-Investigator.

74. Phase I Double-Blind, Placebo-Controlled, Study of the Clinical Pharmacology of Multiple

Doses of CP-143,867 in Healthy Male Subjects (175-006), 1995. Pfizer, Inc. Co-

Investigator.

75. Phase I Open Pilot Study to Compare the Pharmacokinetics of Ziprasidone Administered as 2

X 20 mg Research Capsules and as a 40 mg Proposed Commercial Suspension in Normal

Healthy Subjects (128-034-501), 1995. Pfizer, Inc. Principal Investigator.

76. Phase I Study to Evaluate the Pharmacokinetic Interaction Between Rifabutin and the

Macrolides Azithromycin and Clarithromycin in Healthy Subjects (066-074-501), 1995.

Pfizer, Inc. Principal Investigator.

77. The Effect of Trovafloxacin on the Pharmacodynamics of Warfarin in Healthy Male Subjects

(154-034-501), 1995. Pfizer, Inc. Principal Investigator.

78. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 300 Mg Oral Dose of

CP-195,543 Administered as a Capsule Under Fasting and Fed Conditions and as a

Suspension Under Fasting Conditions in Healthy Volunteers (207-003-501), 1995. Pfizer,


79. Phase I Open Study to Evaluate Renal Function in Normal, Healthy Male Volunteers (064-

408-501), 1995. Pfizer, Inc. Principal Investigator.


Pharmacokinetics of CJ-12,255 Following Escalating Single Oral Doses in Healthy Male

Subjects (219-001), 1995. Pfizer, Inc. Principal Investigator.

81. Phase I Double-Blind, Parallel, Placebo-Controlled Pilot Study to Assess the Safety,

Toleration and Pharmacokinetics of Oral Sertraline Administered as a Single Dose and Over

a Defined Period of Time to Normal, Healthy Male or Female Volunteers, Part II (050-032),


82. Evaluation of Methods for Rapid Screening of Polymorphic Metabolism Status Using

Dextromethorphan as a Probe in Normal, Healthy Subjects (161-402-9501), 1996. Pfizer,


83. Phase I Open Study to Assess the Potential of a CYP 2D6 Interaction of Ziprasidone Using

Dextromethorphan in Normal, Healthy Subjects (128-048-501), 1996. Pfizer, Inc. Co-

Investigator.


84. Phase I Open Crossover Study of the Relative Bioavailability of CJ-12,255 Administered as a

Solution in the Fasted and Postprandial States (219-002-9501), 1996. Pfizer, Inc. Principal

Investigator.

85. Phase I Study to Determine the Excretion into Breast Milk and Pharmacokinetics After

Single Oral Dose Administration of Eletriptan in Normal, Healthy Nursing Women (160-

003-9501), 1996. Pfizer, Inc. Principal Investigator.

86. A Study to Assess the Effect of a Single 1200 mg Dose of Azithromycin on the

Pharmacokinetics of Indinavir (066-085-9501), 1996. Pfizer, Inc. Principal Investigator.

87. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 100 mg Oral Dose of

CP-88,144 Administered as a Capsule Under Fasting and Fed Conditions to Healthy


88. Phase I Study to Determine the Influence of Different Phases of the Menstrual Cycle on the

Pharmacokinetics After Single Oral Dose Administration of Eletriptan in Normal, Healthy

Female Subjects (160-004-9501), 1997. Pfizer, Inc. Principal Investigator.

89. The Effect of Amlodipine on the Pharmacokinetics of Atorvastatin in Healthy Male Subjects

(053-019-80B), 1997. Pfizer, Inc. Principal Investigator.

90. Phase I Open Study to Compare the Bioavailability of Pseudoephedrine Administered as an

asymmetric membrane technology (AMT) tablet versus Efidac/24® After Single Dose

Administration to Normal Healthy Subjects (S/B 97Ck16-0705/97-N-001 and 143-002-


91. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 10 mg Oral Dose of

CP-361,428 Administered as a Tablet Under Fasting and Fed Conditions to Healthy



Pharmacokinetics of CP-409,092 Following Escalating Single Oral Doses in Healthy Male

Subjects (270-001-9501), 1997. Pfizer, Inc. Principal Investigator.

93. Evaluation of the Efficacy of Gallium Nitrate in the Treatment of Sarcoidosis, 1997. Ben

Venue Laboratories. Principal Investigator.

94. An Open-label, Multiple Dose, Two-way Crossover Comparison of Efidac/24® versus

Sudafed® in Healthy Subjects (143-401-9501), 1997. Pfizer, Inc. Principal Investigator.

95. Escalating, Single Dose, Placebo-Controlled, Double-Blind, Randomized, Safety, Toleration,

Pharmacokinetic and Pharmacodynamic Study of CP-368,296 Administered orally to

Normal, Healthy Subjects and Non-Insulin Dependent Diabetic Subjects (263-001-9501).



96. Phase I Study to Determine the Influence of Different Phases of the Menstrual Cycle on

Leukocyte Counts and Leukocyte Profiles, 1997. Pfizer, Inc. Principal Investigator.

97. The Effect of Food and Time of Drug Administration in the Safety and Toleration of

Trovafloxacin in Young Female Subjects (154-055-9501), 1997. Pfizer, Inc. Principal

Investigator.

98. Phase I Study to Examine the Serum Concentrations of CP-66,458 Following Administration

of Azithromycin as Capsules and Tablets in the Fasted and Fed States (066-093-9501), 1997.


99. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration,

Pharmacokinetics of CJ-11,974 in Healthy, Elderly Volunteers (167-007-9501), 1997.


100. Phase I Double-Blind, Placebo-Controlled Study of the Clinical Pharmacology of CP-

409,092 Following Multiple Dosing in Healthy Male Subjects (270-003-9501), 1997-8.


101. An Open, 3-Way Single Dose, Crossover Study to Determine the Pharmacokinetics of CP-

409,092 under Fasting and Fed Conditions in Healthy Male Subjects (270-002-9501), 1998.


102. Phase I Open Pilot Evaluation of the Effect of Food on the Bioavailability of a Controlled

Release CP-409,092 Dosage Form Relative to a Fasting Solution Dose in Healthy Male

Subjects (270-006-9501), 1998. Pfizer, Inc. Principal Investigator.

103. Phase I Open Pilot Evaluation of the Bioavailability of Two Controlled Release CP-409,092

Dosage Forms Relative to a Solution Dose in Healthy Male Subjects (270-007-9501), 1998.


104. Phase I Study of the Clinical Pharmacology of CP-409,092 Following Multiple Dosing in

Healthy Male Subjects Previously Exposed to CP-409,092 (270-010-9501), 1999. Pfizer,


105. Evaluation of Potential Effects of 20-mg V20001 on Urinary Excretion Ratio of 6-β-

Hydroxycortisol to Cortisol in Patients with Type 2 Diabetes Mellitus (KD98-1001), 1999-

2000. Purdue Pharma L.P. Principal Investigator.

106. An Open-Label Study to Determine the Apparent Time to Steady-State Plasma

Concentrations Following the Application of Buprenorphine Transdermal System (BTDS)

and the Effects of Local Heat on the Plasma Concentrations of Buprenorphine After BTDS

Removal (BP99-0204), 1999. Purdue Pharma L.P. Principal Investigator.


107. An Open-Label Study in Normal Subjects and Subjects Without Gallbladders to Determine

Whether Hydromorphone Undergoes Enterohepatic Recirculation (HD98-0504), 1999.

Purdue Pharma L.P. Principal Investigator.

108. A Single-Dose, Open-Label, Randomized, Three-Period, Six-Sequence, Three-Treatment

Crossover Study Comparing Controlled and Immediate-Release Hydrocodone Tablets and

Assessing the Effect of Food on Controlled-Release Hydrocodone Tablets (HCD-1001),

1999. Purdue Pharma L.P. Principal Investigator.

109. A Phase 1, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence of

Enoxaparin Using an Autoinjector Versus a Standard Injection of 40 mg in Healthy Male and

Female Volunteers (RP54563Q-153), 2000. Aventis Pharmaceuticals Inc. Principal

Investigator.

110. A Double-Blind, Placebo Controlled, Escalating Single Dose Study of the Safety,

Tolerability and Pharmacokinetics of V102862 in Healthy Volunteers (CSC-1001), 2000.


111. Phase II, Double-Blind and Placebo-Controlled Methodology Study to Assess the Effect of

Immediate-Release Paroxetine and Sertraline Using a Controlled-Release Formulation

Prototype on Sexual Function (A0501025), 2000. Pfizer, Inc. Principal Investigator.

112. A Parallel Open-Label Study to Examine Plasma Concentrations of Buprenorphine

Following Reapplication of 10-mg Buprenorphine Transdermal System (BTDS) After

Variable Application Site Rest Periods in Healthy Subjects (BUP1002), 2000. Purdue

Pharma L.P. Principal Investigator.

113. Phase II, Double-Blind and Placebo-Controlled Study to Assess the Effect of CP-122,721 on

Sexual Function (CP-122,721), 2000. Pfizer, Inc. Principal Investigator.

114. A Four-Way Open-Label, Randomized Crossover Study with Talwin® Nx, Single-Dose Oral

Naloxone, Divided-Dose Oral Naloxone, and Intravenous Naloxone in Healthy Subjects,

2001. Purdue Pharma, L.P. Principal Investigator.

115. A Double-Blind Placebo-Controlled, Parallel Group Design Dose-Ranging Study of Three

Doses of Lasofoxifene vs. Placebo for the Treatment of Sexual Dysfunction (Arousal

Disorder) in Postmenopausal Women (A2181015), 2002. Pfizer, Inc. Principal Investigator.

116. A Double-Blind Placebo-Controlled, Parallel Group Design Dose-Ranging Study of Three

Doses of Lasofoxifene vs. Placebo for the Treatment of Sexual Dysfunction (Hypoactive

Desire) in Postmenopausal Women (A2181021), 2002. Pfizer, Inc. Principal Investigator.

117. A Study of the Safety and Efficacy of Lasofoxifene in the Treatment of Vaginal Atrophy in

Postmenopausal Women (A2181012), 2002. Pfizer, Inc. Principal Investigator.


118. Collection of Human Plasma from Healthy Volunteers Following a High-Fat Meal and

Human Serum from Capillary Blood Obtained via Finger Sticks (OXU9002), 2002. Purdue

Pharma L.P. Principal Investigator.

119. A Phase 1, Single-Center, Open-Label, Study to Evaluate The Effect of Multiple Intravenous

Doses of Repifermin on Proliferation and Thickening of the Oral Mucosa and Whole Saliva

Production in Healthy Subjects (KGF-2-M10), 2002. Human Genome Sciences, Inc.


120. Tolerability of Oral Naltrexone in Patients Receiving OxyContin (OCX1001), 2002. Purdue

Pharma, L.P. Principal Investigator.

121. Study to Determine the Stability of Drugs in Clotted Blood from Healthy Volunteers

(OXP9001), 2002. Purdue Pharma, L.P. Principal Investigator.

122. Phase I Study to Determine the Optimal Configuration of ALGRX 3268 (3268-1-100-001),

2002. AlgoRx Pharmaceuticals. Principal Investigator.

123. Tacrolimus Pharmacokinetics in Adult Atopic Dermatitis Patients After Topical

Administration of Tacrolimus Cream 0.01% and 0.03% and Protopic® (Tacrolimus)

ointment 0.03% (01-0-127), 2002. Fujisawa Healthcare, Inc. Principal Investigator.

124. Tacrolimus Pharmacokinetics In Adult Psoriasis Patients After Topical Administration Of

Tacrolimus Cream 0.1% and 0.5% (02-0-139), 2002. Fujisawa Healthcare, Inc. Principal

Investigator.

125. Phase I Study To Quantitate Systemic Lidocaine Exposure after Treatment with ALGRX

3268 (3268-1-101-001), 2002. AlgoRx Pharmaceuticals. Principal Investigator.

126. A Longitudinal Population-Based Study of Peripheral Blood Gene Expression Profiles in

Healthy Volunteers (9999A1-900-WW), 2003. Wyeth Research. Principal Investigator.

127. A Phase 1 Study to Evaluate the Safety and Tolerability of Hydrocodone/Naltrexone/

Acetaminophen (HXA) Combination Tablet in Healthy Subjects (HXA1017), 2003. Purdue

Pharma, L.P. Principal Investigator.

128. Phase I Study to Determine the Optimal Configuration of ALGRX 3268 for the Back of the

Hand (3268-1-102-001), 2003. AlgoRx Pharmaceuticals. Principal Investigator.

129. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a V134444 Oral

Suspension Following AM Administration in Healthy Male Adults (CSH1001), 2003.

Purdue Pharma, L.P. Principal Investigator.


130. An Exploratory Pharmacogenomic Study of Estrogen-Regulated Genes in the Human Vagina

of Postmenopausal Women with Vaginal Atrophy Treated with 17β-estradiol (9800R1-900-

US), 2004. Wyeth Research. Principal Investigator.

131. A Single-center, Open-label, Randomized Investigation in Healthy Volunteers to Determine

the Intranasal Bioavailability of Naltrexone in a Three-way Crossover Study (OCX1009),


132. A Single-Center, Open-Label, Randomized Investigation in Healthy Volunteers to Determine

the Intranasal and Sublingual Bioavailabilities of Naloxone in a Four-way Crossover Study

(OXN1001), 2004. Purdue Pharma, L.P. Principal Investigator.


Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a V112054 Liquid Oral

Formulation Following in Healthy Male Adults (CSB1001), 2004. Purdue Pharma, L.P.


134. An Open-Label, Nonrandomized, 2-Period, Fixed Sequence Study to Investigate the Effect of

Single and Repeat Oral Doses of Esomeprazole on the Single-Dose Pharmacokinetics of

AVANDAMET XR (2 tablets of the DiffCORE combination formulation of rosiglitazone

4mg/metformin 1000 mg) in Healthy Volunteers (SB-712753/901), 2004. GlaxoSmithKline.


135. A Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and

Tolerability of a Single Subfascial/Intramuscular Injection of ALGRX 4975 in Healthy Male

Subjects (4975-1-009-1), 2005. AlgoRx Pharmaceuticals. Principal Investigator.

136. A Randomized Placebo-Controlled Crossover Trial Evaluating the Effect of Naltrexone at 1,

3, and 6 mg Dose Levels on the Abuse Potential of 40 mg Oxycodone in Non-dependent,

Opioid-preferring Subjects (OCX2002), 2005. Purdue Pharma, L.P. Principal Investigator.

137. Phase I, Open-label, Randomized, Two-way Crossover Study in Healthy Subjects to

Determine the Pharmacokinetics and Safety of Aloxi® (Palonosetron HCL I.V.) When

Administered as a 15-minute Infusion Compared to a 30-second Infusion (PALO-04-21),

2005, MGI Pharma, Inc. Principal Investigator.

138. An Open-Label Study to Determine the Sound Emission Levels Produced by a Needle-Free

Injector for Medical Use (ALGRX 3268 ND5.3A) in Healthy Adult Volunteers (3268-1-

005-1), 2005. AlgoRx Pharmaceuticals. Principal Investigator.

139. A 4-Period, Single Ascending Dose, Randomized, Placebo-Controlled, Double-Blind Study

to Evaluate the Safety, Tolerability and Pharmacokinetics in Healthy Postmenopausal

Women of Oral GSK232802, Followed by Staggered Parallel Group, Randomized, Placebo-

Controlled Once Daily Repeated Oral Doses for 4 Weeks (SRM19011), 2005.

GlaxoSmithKline. Principal Investigator.


140. A Randomized, Open-Label, Single-Dose, 14-Treatment, 4-Period, Incomplete Block, Cross

Over Pilot Study in Healthy Male and Female Subjects to Assess the Pharmacokinetic

Characteristics and Relative Bioavailability of Hydromorphone Following Administration of

3 New Palladone Melt Extrusion Multiparticulate Formulations (12 mg) in the Fed and

Fasted State, With and Without Concomitant Ethanol Administration (HMP1015), 2005.


141. Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the

Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204

(AnthimTM) and its Potential Interaction with Ciprofloxacin (AH-101), 2005-2006. Elusys

Pharmaceuticals. Principal Investigator.

142. Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and

Pharmacodynamics of NRI-022 Administered Orally to Healthy Postmenopausal Women

(3190A1-100-US), 2006. Wyeth Research. Principal Investigator.

143. A Randomized, Open-Label, Single-Dose, Four-Way Crossover Pilot Study in Healthy

Subjects to Assess the Pharmacokinetic Characteristics and Relative Bioavailability of

Hydromorphone Following Administration of 3 Different Hydromorphone Tamper

Resistant Formulations (12 mg) in the Fed and Fasted State, Compared to Palladone® (12

mg) in the Fed and Fasted State (HMP1017), 2006. Purdue Pharma L.P. Principal

Investigator.

144. Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single

Intravenous Dose of CBR-2092 in Healthy Volunteers (CBR-2092-001), 2006. Cumbre

Pharmaceuticals Inc. Principal Investigator.

145. An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on

the Pharmacokinetics of GSK189075 (KG2108197), 2007. GlaxoSmithKline. Principal

Investigator.

146. A Phase I, Randomized, Double-Blind Study to Assess the Effects of Repeat Oral Dosing

of Ketoconazole on the Pharmacokinetics of Repeat Oral Dosing of Casopitant in Healthy

Subjects (NKV109990), 2007. GlaxoSmithKline. Principal Investigator.

147. An Open-Label, Randomized, Single Dose, Crossover Study to Assess the

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Modified Release

Formulations of GSK189075 in Healthy Volunteers (KGW111057), 2007. GlaxoSmith-

Kline. Principal Investigator.

148. A Randomized, Single-Blind, Crossover Study to Evaluate the Safety and Onset of Action

of SKY0402 Following Subcutaneous Administration in Healthy Volunteers (SKY0402-

C-106), 2007. Pacira Pharmaceuticals. Principal Investigator.


149. The Pharmacokinetics and Safety of a Single Dose of SEP-225289 Administered With and

Without Food in Healthy Volunteers (360-010), 2007. Sepracor. Principal Investigator.

150. A Study of Selected RNA and Proteomics Characteristics of Normal Healthy Adult and

Pediatric Subjects (0000-RS-0701), 2007. Regeneron Pharmaceuticals, Inc. Principal

Investigator.

151. A Randomized, Double-Blind Study to Evaluate and Compare the Pharmacokinetic and

Pharmacodynamic Properties of Three Manufacturing Lots of SKY0402 Administered via

Local Infiltration to Healthy Volunteers (SKY0402-C-108), 2008. Pacira Pharmaceuticals.


152. An Evaluation of The Safety, Tolerability, and Pharmacodynamic Effects of GSK189075

When Administered with Furosemide or Hydrochlorothiazide (KG2105251), 2008.

GlaxoSmith-Kline. Principal Investigator.


Evaluation of the Safety, Tolerability, and Pharmacokinetics of V113741 in Healthy Males

(POA1001), 2008. Purdue Pharma, L.P. Principal Investigator.

154. A Randomized, Single-Blind, Sequential Cohort, Crossover Study to Evaluate the Onset of

Action of SKY0402 Following Local Infiltration in Healthy Volunteers (SKY0402-C-109),

2009. Pacira Pharmaceuticals. Principal Investigator.

155. Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the

Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204

(AnthimTM) (AH-102), 2009. Elusys Pharmaceuticals. Principal Investigator.

156. Phase I Single-Ascending-Dose Crossover Study to Evaluate the Pharmacokinetics of

N1539 Following Intravenous Administration (N1539-01), 2009. Elan Drug Delivery, Inc.


157. A Randomized, Single-Blind, 3-Way Crossover Study Evaluating the Safety, Tolerability,

and Pharmacokinetics of Crushed Intranasal Oxycodone Tamper Resistant Tablets (OTR)

and OxyContin in Healthy Adults (OTR1021), 2009. Purdue Pharma, L.P. Principal

Investigator.

158. A Study in Type 2 Diabetic Subjects of Single and Multiple Doses of Orally Administered

GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and

Pharmacodynamics of the Compound (GPR111598), 2009. GlaxoSmithKline. Principal

Investigator.

159. Randomized Crossover Study to Evaluate the Pharmacokinetics of Hyoscyamine as

Symax® DuoTab and as Symax® SL in Comparison with Hyoscyamine Sulfate Oral

Solution (SOVCT-0024-001), 2009. Capellon Pharmaceuticals, Ltd. Principal

Investigator.


160. A single-center, randomized, open-label, multiple-application study in healthy subjects to

determine the apparent time to steady state of buprenorphine delivered by a transdermal

system (BUP1020), 2010. Purdue Pharma, L.P. Principal Investigator.


Evaluation of the Safety, Tolerability, and Pharmacokinetics of V116517 in Healthy Males

(VND1001), 2010. Purdue Pharma, L.P. Subinvestigator.

162. Multiple Dose Study to Evaluate the Steady-State Pharmacokinetics and Food Effect of

Hyoscyamine as Symax® SL and as Symax® DuoTab (SOVCT-00244-002), 2010.

Capellon Pharmaceuticals, Ltd. Principal Investigator.

163. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Multiple-

Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of V116517 in Healthy

Male Subjects (VND1002), 2011. Purdue Pharma, L.P. Principal Investigator.

164. A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Multiple-

Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of V113741 in Healthy

Male Subjects (POA1002), 2011. Purdue Pharma, L.P. Principal Investigator.

165. Phase I Single- and Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability,

and Pharmacokinetics of N1814 Following Intramuscular Administration (N1814-01),

2011. Elan Drug Delivery, Inc. Principal Investigator.

166. A Randomized, Crossover, Pilot Study in Healthy Subjects to Assess the

Pharmacokinetics and Abuse-Deterrent Properties of Oxycodone Immediate-Release

Formulations (OCI1001), 2012. Purdue Pharma, L.P. Principal Investigator.

167. An Assessment of the Safety and Pharmacokinetics of Intranasal (“Snorted”)

Administration of Crushed Oxycodone DETERx™ 40 mg, Oral Administration of Intact

Oxycodone DETERx™ 40 mg, and Intranasal Oxycodone Powder 40 mg (CP-OXYDET-

19), 2013. Collegium Pharmaceutical, Inc. Principal Investigator.

168. A Pilot Study in Healthy Subjects to Compare Objective and Subjective Measurements of

Induced Pain (BNA1001), 2013. Purdue Pharma, L.P. Principal Investigator.

169. A Single-Center, Randomized, Double-Blind Crossover Study to Evaluate the Abuse

Potential, Pharmacokinetics, and Safety of Crushed and Intranasally Administered

Immediate Release Oxycodone (OCI) Tablets in Recreational Opioid Users (OCI1005),


170. A Pilot Study in Healthy Subjects to Quantitate Reductions in Pain Perception Following

the Administration of OxyContin® (BNA1002), 2014. Purdue Pharma, L.P. Principal

Investigator.


171. Clinical Trial Protocol for the Establishment of Normative Data of Brain Network

Activation (BNA) Using Evoked Response Potentials in Adolescents, Young Adults and

Adults (ELM-25), 2015. ElMindA, Ltd. Principal Investigator.

GRANTS FROM WITHIN OHIO STATE UNIVERSITY

An Open, Phase I, Multiple-Dose, Pilot Study to Investigate the Concentrations of Ellagic Acid and

Anthocyanins in Plasma, and the Excretion of 8-Oxo-7, 8-Dihydro-2'-Deoxyguanosine (8-OHdG),

in Healthy Volunteers Dosed Orally for 14 Days with a Powdered Formulation of Freeze-Dried

Black Raspberries, 2002. Environmental Health Sciences. Co-Principal Investigator.

An Open-Label, Phase I, Multi-Fixed-Dose, Pilot Study to Investigate the Pharmacokinetics of

Ellagic Acid and Anthocyanins and Safety in Healthy Volunteers Dosed Orally for 7 Days with a

Powdered Formulation of Freeze-Dried Black Raspberries, 2004. Environmental Health Sciences.

Co-Principal Investigator.

FEDERAL GRANTS

Influence of Calcium on Bone Mass Formation During Puberty, NIH, $2,952,426. Co-Investigator

with Velimir Matkovic, M.D., Ph.D., September, 1991 to 1996.

USE PATENTS

Use of gallium nitrate in the treatment of endotoxic shock, filed 1995, in collaboration with Dr.

Nicholas Gerber, Dr. Daniel Mullet, and Mary E. Krecic, awarded 1997.

Treatment of pulmonary inflammation with gallium, filed 1996, in collaboration with Dr. Daniel

Mullet and Dr. Nicholas Gerber, awarded December 23, 1997, patent number 5,700,487.

Documents

GLEN APSELOFF, M - Ohio Clinical Trials, Inc.GLEN APSELOFF, M.D., F.C.P. Ohio Clinical Trials, Inc. 1380 Edgehill Road Columbus, OH 43212 Office: (614) 754-1570 Fax: (614) 291-0817