drugset / Trial / NCT01923870

Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function

NCT01923870

Phase 1 Completed 19 enrolled Repros Therapeutics Inc.
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

* To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function. * To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.

Timeline

Start
2013-08
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Androxal Unknown 25 mg

Indications