A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the abuse potential of ALKS 5461.

Official Title
-----------------
A Phase 1, Single-Dose, Double-Blind, Placebo-and Active-Controlled, Randomized, 6-way Crossover Human Abuse Liability Evaluation of ALKS 5461

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ALKS 5461
* Drug: Buprenorphine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal Be willing and able to abide by all study requirements and restrictions Additional criteria may apply Exclusion Criteria: Have evidence of drug or alcohol dependence within the past 2 years Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting Be currently pregnant, breastfeeding, or planning to become pregnant during the study Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone) Have a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) Have donated or lost more than 500 mL whole blood Additional criteria may apply.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 5461 Dose 1<br>Sublingual tablets | Drug: ALKS 5461<br>* Sublingual tablets, single administration<br>|
| Experimental: ALKS 5461 Dose 2<br>Sublingual tablets | Drug: ALKS 5461<br>* Sublingual tablets, single administration<br>|
| Experimental: ALKS 5461 Dose 3<br>Sublingual tablets | Drug: ALKS 5461<br>* Sublingual tablets, single administration<br>|
| Active Comparator: Buprenorphine Dose 1<br>Sublingual tablets | Drug: Buprenorphine<br>* Sublingual tablets, single administration<br>|
| Active Comparator: Buprenorphine Dose 2<br>Sublingual tablets | Drug: Buprenorphine<br>* Sublingual tablets, single administration<br>|
| Placebo Comparator: Placebo<br>Sublingual tablets | Drug: Placebo<br>* Sublingual tablets, single administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: Abuse potential measured by visual analog scales (VAS) |  | Approximately 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events (AEs) |  | Up to 14 weeks | 
| Pharmacokinetics: Plasma concentrations of ALKS 5461 |  | Up to 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteer, Abuse Liability, ALKS 5461, Alkermes