Pharmacokinetics of GS-9883 in Adults With Normal and Impaired Renal Function

Status:	Completed
Conditions:	Renal Impairment / Chronic Kidney Disease, HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases, Nephrology / Urology
Healthy:	No
Age Range:	18 - 79
Updated:	4/21/2016
Start Date:	April 2015
End Date:	July 2015

A Phase 1, Open-Label, Parallel-Group, Adaptive Single-dose Study to Evaluate the Pharmacokinetics of GS-9883 in Subjects With Normal and Impaired Renal Function

This study will evaluate the pharmacokinetic (PK) profile, safety, and tolerability of oral
GS-9883 in adults with impaired renal function relative to matched, healthy controls with
normal renal function. Each participant in the renal impairment groups will be matched for
age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m^2)] with a
participant in the control group.

Inclusion Criteria:

- All Individuals:

- Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening

- Individuals with impaired renal function

- Chronic stable renal impairment without recent clinical change

- Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min

- Moderate: CrCl = 30 - 59 mL/min

- Severe: CrCl = 15 - 29 mL/min

- Healthy individuals

- CrCl ≥ 90 mL/min

Exclusion Criteria:

- All Individuals:

- Pregnant or lactating females

- HIV positive or chronic hepatitis B infected

- Individuals with impaired renal function

- Chronic liver disease

- Dialysis or anticipated use of dialysis

- Renal transplant

We found this trial at

sites

Orlando Clinical Research Center

5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806

407-240-7878