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NCT01991327 · ClinicalTrials.gov registry record · Phase 1
Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males
A Phase 1 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01991327: Completed Phase 1 study, sponsored by Repros Therapeutics.
NCT01991327 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01991327, a Phase 1 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Androxal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01991327 record still lists
NCT01991327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01991327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01991327 about?
NCT01991327 is a clinical study titled "Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males". 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 w...
What is the current status of trial NCT01991327?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-05. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01991327?
The interventions under investigation include: Placebo (DRUG), Androxal (DRUG).
Who is sponsoring clinical trial NCT01991327?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01991327's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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