A Water Consumption 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 water consumption on the pharmacokinetics of ALKS 5461.

Official Title
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A Phase 1 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461

Conditions
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Healthy

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 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 of 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 administered followed by consumption of 240 mL (8 ounces) of water at different timepoints<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461 | Up to 72 hours | 
| AUClast | Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461 | Up to 72 hours | 
| Cmax | Maximum observed plasma concentration for ALKS 5461 | Up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be measured by the incidence of Adverse Effects |  | Up to 46 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