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NCT02545439 · ClinicalTrials.gov registry record · Phase 1
A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers
A Phase 1 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02545439: Completed Phase 1 study, sponsored by Alkermes.
NCT02545439 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02545439, a Phase 1 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.
Primary Outcome
Area under the concentration time curve from 0 to infinity of ALKS 5461 in the presence and absence of rifampin
Interventions
- DRUG ALKS 5461
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-07 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
What the finished NCT02545439 record still lists
NCT02545439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which ALKS 5461 is the first listed.
NCT02545439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02545439 about?
NCT02545439 is a clinical study titled "A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers". This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.
What is the current status of trial NCT02545439?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-07. Estimated completion is 2015-10.
What interventions are being tested in trial NCT02545439?
The interventions under investigation include: ALKS 5461 (DRUG).
Who is sponsoring clinical trial NCT02545439?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02545439's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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