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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 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02504463
The ClinicalTrials.gov registry entry for NCT02504463 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Samidorphan IV is the first listed.
NCT02504463 reports 0 study locations.
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.
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