CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
Androxal +1 moredrug
Likely dose
Androxal 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01959685
NCT01959685Phase 1Completed
CompareCT.gov

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

Repros Therapeutics Inc.·interventional·Posted Oct 10, 2013·Updated Aug 11, 2014

In Brief

A Phase 1 clinical trial evaluating Androxal and Placebo for Pharmacokinetics and Tolerability. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics, Tolerability
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 10, 2013
Enrollment StartOct 1, 2013
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.7 years ago

Interventions

Androxaldrug

125 mg Androxal, 250 mg Androxal separated by at least 7 days

Placebodrug

Placebo, single dose