Phase 1
N=33
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
HCV Infection
Bottom Line
View on ClinicalTrials.gov: NCT02397707 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast — 2058.5; 3872.5; 500.1; 601.2 h*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Voxilaprevir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast |
2058.5; 3872.5; 500.1; 601.2 | — |
| PRIMARY PK Parameter of Voxilaprevir: AUCinf |
2227.1; 4107.5; 557.8; 685 | — |
| PRIMARY PK Parameter of Voxilaprevir: Cmax |
189.7; 370.8; 56.1; 51.9 | — |
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%).
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.
Data sourced from ClinicalTrials.gov (NCT02397707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.