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

September 17, 2015 updated by: Alkermes, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body mass index (BMI) of greater than/equal to 19 and less than/equal to 32 kg/m^2 at screening (minimum weight of 50.0 kg)
  • Generally good health
  • Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last dose of the study drug by abstinence from heterosexual relationships or use of a reliable contraceptive method
  • Additional criteria may apply

Exclusion Criteria:

  • Clinically significant illness within 30 days
  • History of alcohol or opioid dependence, or positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
  • History of oral or gastrointestinal disease
  • Irregular bowel or bladder function
  • History of allergy or hypersensitivity to opioid medications or opioid antagonists (eg, naltrexone, naloxone)
  • Current or pending legal charges or probation that would interfere with study conduct
  • Use of alcohol within 24 hours prior to admission or urine positive test for alcohol at screening or admission
  • Tobacco or nicotine use within 90 days
  • Anticipated need for prescription medicines during the study period
  • Additional criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Samidorphan IV
Samidorphan solution for IV administration
Drug: Samidorphan IV
Single IV administration
Experimental: Samidorphan sublingual
[14c]-Samidorphan for sublingual administration
Drug: [14c]-Samidorphan sublingual
Single sublingual administration containing radiolabel
Experimental: Samidorphan oral
[14c]-Samidorphan for oral administration
Drug: [14c]-Samidorphan oral
Single oral administration containing radiolabel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC 0-t
Time Frame: Up to 120 hours after each dose
Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma
Up to 120 hours after each dose
Cmax
Time Frame: Up to 120 hours after each dose
Maximum concentration of total radioactivity in blood and plasma
Up to 120 hours after each dose
Tmax
Time Frame: Up to 120 hours after each dose
Time to maximum concentration of total radioactivity in blood and plasma
Up to 120 hours after each dose
Fe%0-t
Time Frame: Up to 120 hours after each dose
Fraction of dose excreted in urine and feces
Up to 120 hours after each dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability will be measured by the incidence of Adverse Events
Time Frame: Up to 35 days
Up to 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Arielle Stanford, MD, Alkermes Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK33-B107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Samidorphan IV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe