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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: Samidorphan; Drug: Oxycodone

• Registration Number: NCT02218021
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-15
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Samidorphan Dose 2	Samidorphan	-
Samidorphan Dose 1	Samidorphan	-
Samidorphan Dose 3	Samidorphan	-
Oxycodone Dose 1	Oxycodone	-
Oxycodone Dose 2	Oxycodone	-

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)	Approximately 4 weeks

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events (AEs)	Approximately 5.5 weeks
Pharmacokinetics: Plasma concentrations of samidorphan and metabolite	Approximately 4 weeks

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Overland Park, Kansas, United States