Trials / Completed
CompletedNCT01991327
Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males
AN OPEN-LABEL, MULTIPLE DOSE STUDY TO ASSESS THE DRUG-DRUG INTERACTIONS OF ANDROXAL WITH CYTOCHROME P450 ISOENZYMES IN HEALTHY MALE SUBJECTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and tolerability of Androxal will be determined in healthy male subjects administered Androxal 25 mg daily for 3 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Androxal | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2013-11-25
- Last updated
- 2014-08-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01991327. Inclusion in this directory is not an endorsement.