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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01817985

Enrollment

Registered

2013-03-26

Start date

2013-03-31

Completion date

2013-08-31

Last updated

2013-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C (HCV) Infection, Moderate Hepatic Impairment, Severe Hepatic Impairment

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.

Interventions

DRUGGS-5816

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026