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

NCT02504463 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-09-18

No results posted yet for this study

Summary

This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.

Conditions

  • Healthy

Interventions

DRUG

Samidorphan IV

Single IV administration

DRUG

[14c]-Samidorphan sublingual

Single sublingual administration containing radiolabel

DRUG

[14c]-Samidorphan oral

Single oral administration containing radiolabel

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Arielle Stanford, MD · Alkermes Medical Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504463 on ClinicalTrials.gov