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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Velpatasvir

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.