The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers

Phase 1 Completed 37 enrolled Pfizer

RandomizedCrossoverSingle-blind

Summary

The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.

Timeline

Start: 2005-10
Primary completion: 2006-03
Completion: 2006-03

Publications

Fleishaker DL, Mukherjee A, Whaley FS, Daniel S, Zeiher BG. Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study. BMC Musculoskelet Disord. 2016 Jul 16;17:293. doi: 10.1186/s12891-016-1135-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prednisone	Other / unclassified	2.5 mg	Oral
Subject	Prednisone	Other / unclassified	5 mg	Oral
Subject	Prednisone	Other / unclassified	10 mg	Oral
Subject	Prednisone	Other / unclassified	20 mg	Oral
Subject	Prednisone	Other / unclassified	40 mg	Oral
Subject	Prednisone	Other / unclassified	60 mg	Oral

Indications

No indication recorded.