Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

• Status: Completed
• Trial end date: 2016-03-04
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in the healthy control group will be matched to participants with impaired hepatic function by gender, age (± 10 years), and body mass index (± 15%).

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

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• All individuals:

• Screening laboratory values within defined thresholds for group

• Use of two effective contraception methods if female of childbearing potential or sexually active male

• For individuals with moderate hepatic impairment:

• Diagnosis of chronic (> 6 months) hepatic impairment

• Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh Class B).

• For individuals with severe hepatic impairment:

• Diagnosis of chronic (> 6 months) hepatic impairment

• Score on the CPT scale of 10-15 at screening (Child Pugh Class C)

• For individuals with normal hepatic function:

• Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative

Key Exclusion Criteria:

• All individuals:

• Pregnant or nursing female or male with pregnant female partner

• HIV infection

• History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

• For individuals with moderate or severe hepatic impairment:

• Active HCV infection

• Current hepatic encephalopathy

• Variceal bleeding in the last 6 months unless banded

• Prior placement of a portosystemic shunt

• History of hepatorenal or hepatopulmonary syndrome

• Spontaneous bacterial peritonitis currently or within the last 6 months

• Hospitalization within the last 2 months related to cirrhosis

• Confirmed hypotension

• Suspicion of hepatocellular carcinoma

Note: Other protocol defined Inclusion/Exclusion criteria may apply.