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

Launched by ALKERMES, INC. · May 21, 2015

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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