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

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: GS-5816

• Registration Number: NCT01817985
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	GS-5816	(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816.
Cohort 2	GS-5816	(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of GS-5816	Up to one year	The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.

Secondary Outcome Measures

Name	Time	Method
Incidences of adverse events and laboratory abnormalities	Up to one year	The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities.

Trial Locations

Locations (1)

Investigational Site; 🇵🇷 San Juan, Puerto Rico