NCT01817985
Completed
Phase 1
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Overview
- Phase
- Phase 1
- Intervention
- GS-5816
- Conditions
- Chronic Hepatitis C
- Sponsor
- Gilead Sciences
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic parameters of GS-5816
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of chronic (\> 6 months), hepatic impairment.
- •In the opinion of the Investigator, be in good health.
Exclusion Criteria
- •Severe hepatic encephalopathy.
- •Prior placement of a portosystemic shunt.
- •Hepatorenal or hepatopulmonary syndrome.
- •Suspicion of hepatocellular carcinoma.
Arms & Interventions
Cohort 1
(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816.
Intervention: GS-5816
Cohort 2
(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.
Intervention: GS-5816
Outcomes
Primary Outcomes
Pharmacokinetic parameters of GS-5816
Time Frame: Up to one year
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
Secondary Outcomes
- Incidences of adverse events and laboratory abnormalities(Up to one year)
Study Sites (1)
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