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

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