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Completed Phase 1 Interventional Accepts healthy volunteers

A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers

ClinicalTrials.gov ID: NCT02504463

Public ClinicalTrials.gov record NCT02504463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 10:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of Single Doses of [14c]-Samidorphan in Healthy Male Subjects

Study identification

NCT ID
NCT02504463
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Alkermes, Inc.
Industry
Enrollment
10 participants

Conditions and interventions

Conditions

Interventions

  • Samidorphan IV Drug
  • [14c]-Samidorphan sublingual Drug
  • [14c]-Samidorphan oral Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2015
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015
Last update posted
Sep 17, 2015

2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Alkermes Investigational Site Austin Texas 78744

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02504463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 17, 2015 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02504463 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →