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

NCT ID: NCT01817985

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Chronic Hepatitis C

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

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

Group Type EXPERIMENTAL

GS-5816

Intervention Type DRUG

Cohort 2

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

Group Type EXPERIMENTAL

GS-5816

Intervention Type DRUG

Interventions

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GS-5816

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Brainard, M.D.

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Investigational Site

Miami, Florida, United States

Site Status

Investigational Site

Miami, Florida, United States

Site Status

Investigational Site

Orlando, Florida, United States

Site Status

Investigational Site

Orlando, Florida, United States

Site Status

Investigational Site

San Antonio, Texas, United States

Site Status

Investigational Site

San Juan, Puerto Rico, Puerto Rico

Site Status

Countries

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Germany United States Puerto Rico

Other Identifiers

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GS-US-281-0112

Identifier Type: -

Identifier Source: org_study_id