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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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

Key facts

Study ID

NCT02452801

Run by

Alkermes, Inc.

People needed

40

Starts

2015-05-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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