NCT01959685

A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal

A Dose Escalating Study To Determine the Tolerability and Pharmacokinetics of a Single Dose of Androxal in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Detailed description

A dose escalating study to determine the tolerability and pharmacokinetics (PK) of a supra-therapeutic dose of Androxal, up to 250 mg, in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Conditions

• Pharmacokinetics
• Tolerability

Interventions

Type	Name	Description
DRUG	Androxal	125 mg Androxal, 250 mg Androxal separated by at least 7 days
DRUG	Placebo	Placebo, single dose

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-10-10
• Last updated: 2014-08-11
• Results posted: 2014-08-11

Locations

1 site across 1 country: United States