Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function

Study Overview
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Brief Summary
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This study will evaluate the effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461.

Official Title
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A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS 5461 in Subjects With Hepatic Impairment

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: ALKS 5461


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For all subjects: Has a body mass index (BMI) of 18.0-35.0 kg/m2 and a total body weight >50 kg Agrees to use an approved method of contraception for the duration of the study Additional criteria may apply For subjects with hepatic impairment: Has mild, moderate, or severe hepatic impairment Has hepatic dysfunction due to hepatocellular disease Additional criteria may apply Exclusion Criteria: For all subjects: Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than hepatic impairment Has a history of gastrointestinal surgery, excluding appendectomy or cholecystectomy Is pregnant, planning to become pregnant, or lactating Has a history of clinically significant allergy or a hypersensitivity to opioids Additional criteria may apply For subjects with hepatic impairment: Has evidence of hepatocellular carcinoma, acute liver disease, biliary obstruction, severe ascites, severe portal hypertension, surgical systemic shunts, or other clinically relevant liver-related disorder or condition Has received a liver transplant Has had esophageal variceal bleeding in the past 2 months Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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>* Single dose, given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461 |  | Up to 168 hours postdose | 
| Area under the plasma concentration versus time curve from time 0 to time of last measureable concentration (AUC0-last) following a single dose of ALKS 5461 |  | Up to 168 hours postdose | 
| Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461 |  | Up to 168 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach maximum plasma concentration (TMAX) |  | Up to 168 hours postdose | 
| Terminal elimination half-life (T1/2) |  | Up to 168 hours postdose | 
| Apparent clearance (CL/F) |  | Up to 168 hours postdose | 
| Apparent volume of distribution (Vz/F) |  | Up to 168 hours postdose | 
| Incidence of adverse events (AEs) |  | Up to 14 weeks |