Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
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
2 other identifiers
interventional
33
3 countries
4
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%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2015
CompletedStudy Start
First participant enrolled
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2016
CompletedResults Posted
Study results publicly available
March 20, 2020
CompletedApril 9, 2020
April 1, 2020
12 months
March 20, 2015
March 4, 2020
April 2, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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
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.
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
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.
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
Study Arms (2)
Moderate Hepatic Impaired
EXPERIMENTALParticipants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.
Severe Hepatic Impaired
EXPERIMENTALParticipants with severe hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.
Interventions
100 mg tablet administered orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (4)
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
APEX GmbH
München, 81241, Germany
Auckland Clinical Studies
Auckland, 1142, New Zealand
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2015
First Posted
March 25, 2015
Study Start
March 24, 2015
Primary Completion
March 4, 2016
Study Completion
March 4, 2016
Last Updated
April 9, 2020
Results First Posted
March 20, 2020
Record last verified: 2020-04