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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: ALKS 5461

Study type: Interventional

Funder types: Industry

Identifiers

NCT02452801

ALK5461-215

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ALKS 5461

Experimental group

Description:

Sublingual tablet

Treatment:

Drug: ALKS 5461