Pharmacokinetics and Pharmacodynamics of GS-9674 in Adults With Normal and Impaired Hepatic Function

Status:	Completed
Conditions:	Gastrointestinal, Hepatitis
Therapuetic Areas:	Gastroenterology, Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	11/1/2018
Start Date:	July 13, 2016
End Date:	October 16, 2018

A Phase 1 Open-Label, Parallel-Group, Adaptive, Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9674 in Subjects With Normal and Impaired Hepatic Function

The primary objective of this study is to evaluate the single-dose pharmacokinetics of
GS-9674 in adults with impaired hepatic function relative to matched, healthy controls with
normal hepatic function.

Key Inclusion Criteria:

Cohort 1:

- Individuals with mildly impaired and normal hepatic function.

- Individuals with mild hepatic impairment must have a score of 5-6 on the CPT
Classification at Screening without evidence of worsening clinical and/or laboratory
signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 2:

- Individuals with moderately impaired and normal hepatic function.

- Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT
Classification at Screening without evidence of worsening clinical and/or laboratory
signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 3:

- Individuals with severely impaired and normal hepatic function.

- Individuals with severe hepatic impairment must have a score of 10-15 on the CPT
Classification at Screening without evidence of worsening clinical and/or laboratory
signs of hepatic impairment within 2 months prior or within the screening period.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

We found this trial at

sites

Clinical Trial Facility in Knoxville Tennessee

Knoxville, Tennessee 37920

from

Knoxville, TN