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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01817985

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: GS-5816	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 (N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816.	Drug: GS-5816
Experimental: Cohort 2 (N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.	Drug: GS-5816

Arm

Intervention/Treatment

Experimental: Cohort 1

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

Drug: GS-5816

Experimental: Cohort 2

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

Drug: GS-5816

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Miami	Florida	United States	33014
2	Investigational Site	Miami	Florida	United States	33169
3	Investigational Site	Orlando	Florida	United States	32806
4	Investigational Site	Orlando	Florida	United States	32809
5	Investigational Site	San Antonio	Texas	United States	78215
6	Investigational Site	San Juan		Puerto Rico	00927