Trials / Completed
CompletedNCT02117830
A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase I, single-site, randomized, double-blinded, double-dummy, placebo- and positive-controlled, 4-period crossover study to evaluate the effect of two dose levels of Androxal on cardiac repolarization. Baseline ECGs will be obtained prior to dosing in each Period and ECGs will be obtained during expected peak plasma concentrations of Androxal and the positive control. In each Treatment Period subjects will be admitted to a Clinical Research Unit where study drug will be administered as three (3) daily single doses. Treatment Periods will be separated by a washout of at least 7 days between Periods.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Androxal 25 mg capsules | |
| DRUG | Androxal 250 Capsules | |
| DRUG | Placebo Capsules | |
| DRUG | Moxifloxacin 400 mg |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2014-05-01
- First posted
- 2014-04-21
- Last updated
- 2014-06-16
Source: ClinicalTrials.gov record NCT02117830. Inclusion in this directory is not an endorsement.