A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

Completed · Phase 1

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT01817985

Run by

Gilead Sciences

People needed

33

Starts

2013-03-01

Expected to finish

2013-08-01

Last updated by the study team

2013-08-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of chronic (> 6 months), hepatic impairment.
• In the opinion of the Investigator, be in good health.

You may not qualify if…

• Severe hepatic encephalopathy.
• Prior placement of a portosystemic shunt.
• Hepatorenal or hepatopulmonary syndrome.
• Suspicion of hepatocellular carcinoma.

Where it is running

• Investigational Site — Miami, Florida, United States
• Investigational Site — Miami, Florida, United States
• Investigational Site — Orlando, Florida, United States
• Investigational Site — Orlando, Florida, United States
• Investigational Site — San Antonio, Texas, United States
• Investigational Site — San Juan, Puerto Rico, Puerto Rico

Full record on ClinicalTrials.gov

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