A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Abuse Potential and Safety of Orally Administered Samidorphan in Non-Dependent Recreational Opioid Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218021
• Other study ID #: ALK33-012
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2014
• Last updated: December 1, 2014
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Be in good general physical health

• Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg

• Recreational opioid use experience for non-therapeutic purposes (at >/= 10 times in lifetime and >/= 1 in previous 3 months

• Agree to use an approved method of birth control for the duration of the study

• Additional criteria may apply

Exclusion Criteria:

• Currently pregnant or breastfeeding

• History of or current infection with hepatitis B virus, hepatitis C virus or HIV

• Current or history of any clinically significant medical or psychiatric condition

• Current or history of in the last 2 years of dependence on alcohol or any illicit drugs

• Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days

• Have a history of intolerance or hypersensitivity to opioid antagonists, opioid agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)

• Additional criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Samidorphan

• Placebo

• Oxycodone

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)		Approximately 4 weeks	No
Secondary	Safety: Incidence of adverse events (AEs)		Approximately 5.5 weeks	Yes
Secondary	Pharmacokinetics: Plasma concentrations of samidorphan and metabolite		Approximately 4 weeks	No