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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: Voxilaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02397707

GS-US-338-1126

2015-000342-30 (EudraCT Number)

Details and patient eligibility

About

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%).

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Moderate Hepatic Impaired

Experimental group

Description:

Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.

Treatment:

Drug: Voxilaprevir

Severe Hepatic Impaired

Experimental group

Description:

Participants with severe hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.

Treatment:

Drug: Voxilaprevir