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

Gilead Sciences33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

GS-5816DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

Investigational Site

Miami, Florida, United States

Investigational Site

Miami, Florida, United States

Investigational Site

Orlando, Florida, United States

Investigational Site

Orlando, Florida, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters of GS-5816

The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.

Time frame: Up to one year

Secondary Outcomes

Incidences of adverse events and laboratory abnormalities

The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities.

Time frame: Up to one year

Data from ClinicalTrials.gov

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