A Study of ALKS 5461 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a study to test the safety of ALKS 5461 in healthy adults.

Official Title
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A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects

Conditions
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Pharmacokinetics

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be in good physical health Body mass index of 18-30 kg/m2 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 Human Immunodeficiency Virus (HIV) Current or history of any clinically significant medical or psychiatric condition Current abuse or dependence on alcohol or any illicit drugs Have used nicotine within 90 days Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days 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 used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 5461-A<br> | Drug: ALKS 5461<br>* Sublingual tablet<br>|
| Experimental: ALKS 5461-B<br> | Drug: ALKS 5461<br>* Sublingual tablet<br>|
| Experimental: ALKS 5461 Dose 1<br> | Drug: ALKS 5461<br>* Sublingual tablet<br>|
| Experimental: ALKS 5461 Dose 2<br> | Drug: ALKS 5461<br>* Sublingual tablet<br>|
| Experimental: ALKS 5461 Dose 3<br> | Drug: ALKS 5461<br>* Sublingual tablet<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Sublingual tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability of ALKS 5461 treatment groups | The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity). | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Incidence of adverse events |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALKS 5461, samidorphan