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NCT02504463 · ClinicalTrials.gov registry record · Phase 1
A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
A Phase 1 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02504463: Completed Phase 1 study, sponsored by Alkermes.
NCT02504463 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02504463, a Phase 1 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.
Primary Outcome
Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma
Interventions
- DRUG Samidorphan IV
- DRUG [14c]-Samidorphan sublingual
- DRUG [14c]-Samidorphan oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT02504463 record still lists
NCT02504463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Samidorphan IV is the first listed.
NCT02504463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02504463 about?
NCT02504463 is a clinical study titled "A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers". This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.
What is the current status of trial NCT02504463?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02504463?
The interventions under investigation include: Samidorphan IV (DRUG), [14c]-Samidorphan sublingual (DRUG), [14c]-Samidorphan oral (DRUG).
Who is sponsoring clinical trial NCT02504463?
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 NCT02504463's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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