Status:
COMPLETED
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Diagnosis of chronic (\> 6 months), hepatic impairment.
- In the opinion of the Investigator, be in good health.
Exclusion
- Severe hepatic encephalopathy.
- Prior placement of a portosystemic shunt.
- Hepatorenal or hepatopulmonary syndrome.
- Suspicion of hepatocellular carcinoma.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01817985
Start Date
March 1 2013
End Date
August 1 2013
Last Update
August 29 2013
Active Locations (6)
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1
Investigational Site
Miami, Florida, United States, 33014
2
Investigational Site
Miami, Florida, United States, 33169
3
Investigational Site
Orlando, Florida, United States, 32806
4
Investigational Site
Orlando, Florida, United States, 32809