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

NCT ID: NCT02397707

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-24
• Study Completion Date: 2016-03-04

Brief 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%).

Conditions

HCV Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate Hepatic Impaired

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

Group Type: EXPERIMENTAL

Voxilaprevir

Intervention Type: DRUG

100 mg tablet administered orally

Severe Hepatic Impaired

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

Group Type: EXPERIMENTAL

Voxilaprevir

Intervention Type: DRUG

100 mg tablet administered orally

Interventions

Voxilaprevir

100 mg tablet administered orally

Intervention Type: DRUG

Other Intervention Names

GS-9857

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Texas Liver Institute

San Antonio, Texas, United States

APEX GmbH

München, , Germany

Auckland Clinical Studies

Auckland, , New Zealand

Countries

United States; Germany; New Zealand

References

Lawitz E, Marbury T, Kirby BJ, Au NT, Mathias A, Stamm LM, et al. The Effect of Renal or Hepatic Impairment on the Pharmacokinetics of GS-9857, A Pan-Genotypic HCV NS3/4A Protease Inhibitor [Abstract FRI-167]. J Hepatology 2016:S613-S4.

Reference Type: RESULT

Other Identifiers

2015-000342-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-338-1126

Identifier Type: -

Identifier Source: org_study_id