NCT01923870

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

An Open Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 70 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 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.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Androxal 25 mg

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-08-16
• Last updated: 2014-01-24

Locations

1 site across 1 country: United States