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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: GS-5816

Study type: Interventional

Funder types: Industry

Identifiers

NCT01817985

GS-US-281-0112

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Cohort 1

Experimental group

Description:

(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816.

Treatment:

Drug: GS-5816

Cohort 2

Experimental group

Description:

(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.

Treatment:

Drug: GS-5816