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

Primary Purpose

HCV Infection

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Voxilaprevir
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Orlando Clinical Research Center
  • Texas Liver Institute
  • APEX GmbH
  • Auckland Clinical Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Moderate Hepatic Impaired

Severe Hepatic Impaired

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.
PK Parameter of Voxilaprevir: AUCinf
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.
PK Parameter of Voxilaprevir: Cmax
Cmax is defined as the maximum observed plasma concentration of drug.Data presented are unadjusted geometric means and confidence intervals.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2015
Last Updated
April 2, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02397707
Brief Title
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Official Title
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 24, 2015 (Actual)
Primary Completion Date
March 4, 2016 (Actual)
Study Completion Date
March 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Hepatic Impaired
Arm Type
Experimental
Arm Description
Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.
Arm Title
Severe Hepatic Impaired
Arm Type
Experimental
Arm Description
Participants with severe hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.
Intervention Type
Drug
Intervention Name(s)
Voxilaprevir
Other Intervention Name(s)
GS-9857
Intervention Description
100 mg tablet administered orally
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
Description
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.
Time Frame
0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
Title
PK Parameter of Voxilaprevir: AUCinf
Description
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.
Time Frame
0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
Title
PK Parameter of Voxilaprevir: Cmax
Description
Cmax is defined as the maximum observed plasma concentration of drug.Data presented are unadjusted geometric means and confidence intervals.
Time Frame
0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
APEX GmbH
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Auckland Clinical Studies
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result

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

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