drugset / Trial / NCT01923857

Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function

NCT01923857

Phase 1 Completed 26 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 various stages of renal impairment and in volunteers with normal renal function. * To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Androxal Unknown 25 mg

Indications