Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Completed · Phase 1
Conditions studied: HCV Infection
In brief
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%).
Key facts
- Study ID
- NCT02397707
- Run by
- Gilead Sciences
- People needed
- 33
- Starts
- 2015-03-24
- Expected to finish
- 2016-03-04
- Last updated by the study team
- 2020-04-09
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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