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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

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