A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males

NCT03198013 ↗

Phase 1 Completed 120 enrolled Bristol-Myers Squibb

RandomizedParallel-groupDouble-blindBasic science

Summary

The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects

Timeline

Start: 2008-11-11
Primary completion: 2009-05-18
Completion: 2009-05-18

Publications

Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BMS-791826	Small molecule	—	Oral
Subject	Prednisolone	Other / unclassified	—	Oral

Indications

No indication recorded.