A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

Study Overview
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Brief Summary
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This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.

Official Title
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A Phase 1 Study to Evaluate the Impact of CYP3A4 Induction on the Single Dose Pharmacokinetics of ALKS 5461

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ALKS 5461


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2 Is in good physical health Agrees to use an approved method of contraception for the duration of the study Additional criteria may apply Exclusion Criteria: Is currently pregnant or breastfeeding Has a lifetime history of substance abuse disorder Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception or prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study Has used alcohol within 72 hours prior to any inpatient period Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day) Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 5461<br>Sublingual tablet | Drug: ALKS 5461<br>* Sublingual tablet given alone and in conjunction with Rifampin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | Area under the concentration time curve from 0 to infinity of ALKS 5461 in the presence and absence of rifampin | Up to 72 hours | 
| AUClast | Area under the concentration time curve from time 0 to the last measurable timepoint in the presence and absence of rifampin | Up to 72 hours | 
| Cmax | Maximum plasma concentration in the presence and absence of rifampin. | Up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be measured by the incidence of Adverse Events |  | UP to 27 days | 

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