A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Drug: GS-5816
- Registration Number
- NCT01817985
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Diagnosis of chronic (> 6 months), hepatic impairment.
- In the opinion of the Investigator, be in good health.
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Exclusion Criteria
- Severe hepatic encephalopathy.
- Prior placement of a portosystemic shunt.
- Hepatorenal or hepatopulmonary syndrome.
- Suspicion of hepatocellular carcinoma.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 GS-5816 (N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816. Cohort 2 GS-5816 (N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters of GS-5816 Up to one year The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
- Secondary Outcome Measures
Name Time Method Incidences of adverse events and laboratory abnormalities Up to one year The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities.
Trial Locations
- Locations (1)
Investigational Site
🇵🇷San Juan, Puerto Rico