NCT01923857

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

A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Androxal 25 mg

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-08-16
• Last updated: 2014-08-11

Locations

2 sites across 1 country: United States