Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects

NCT02070939 ↗

Phase 1 Completed 72 enrolled Pfizer

RandomizedParallel-groupDouble-blindBasic science

Summary

This single and multiple ascending dose study is the first evaluation of PF-0626414, a Selective Androgen Receptor Modulator in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male subjects .

Timeline

Start: 2014-02
Primary completion: 2015-03
Completion: 2015-03

Publications

Bhattacharya I, Tarabar S, Liang Y, Pradhan V, Owens J, Oemar B. Safety, Pharmacokinetic, and Pharmacodynamic Evaluation After Single and Multiple Ascending Doses of a Novel Selective Androgen Receptor Modulator in Healthy Subjects. Clin Ther. 2016 Jun;38(6):1401-1416. doi: 10.1016/j.clinthera.2016.03.025. Epub 2016 Apr 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-06260414	Small molecule	1 mg	Oral
Subject	PF-06260414	Small molecule	3 mg	Oral
Subject	PF-06260414	Small molecule	6 mg	Oral
Subject	PF-06260414	Small molecule	10 mg	Oral
Subject	PF-06260414	Small molecule	30 mg	Oral
Subject	PF-06260414	Small molecule	60 mg	Oral
Subject	PF-06260414	Small molecule	100 mg	Oral
Subject	PF-06260414	Small molecule	200 mg	Oral
Subject	PF-06260414	Small molecule	400 mg	Oral

Indications

No indication recorded.