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

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

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Samidorphan
* Drug: Placebo
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Samidorphan Dose 1<br> | Drug: Samidorphan<br> <br> |
| Experimental: Samidorphan Dose 2<br> | Drug: Samidorphan<br> <br> |
| Experimental: Samidorphan Dose 3<br> | Drug: Samidorphan<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Oxycodone Dose 1<br> | Drug: Oxycodone<br> <br> |
| Active Comparator: Oxycodone Dose 2<br> | Drug: Oxycodone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: Abuse potential measured by visual analog scales (VAS) |  | Approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events (AEs) |  | Approximately 5.5 weeks | 
| Pharmacokinetics: Plasma concentrations of samidorphan and metabolite |  | Approximately 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, ALKS 33, ALKS 5461, Samidorphan