Trials / Completed
CompletedNCT02504463
A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of Single Doses of [14c]-Samidorphan in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Samidorphan IV | Single IV administration |
| DRUG | [14c]-Samidorphan sublingual | Single sublingual administration containing radiolabel |
| DRUG | [14c]-Samidorphan oral | Single oral administration containing radiolabel |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2015-07-22
- Last updated
- 2015-09-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02504463. Inclusion in this directory is not an endorsement.