Pharmacokinetics of GS-9857 in Adults With Normal Renal Function and Severe Renal Impairment



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

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A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Renal Function and Severe Renal Impairment

This study will evaluate the pharmacokinetics, safety, and tolerability of GS-9857 in adults
with severe renal impairment and matched healthy control adults.


Inclusion Criteria:

- All individuals:

- Screening laboratory values within defined thresholds for group

- Use of two effective contraception methods if female of childbearing potential
or sexually active male

- For individuals with severe renal impairment:

- Stable chronic kidney disease

- Creatinine clearance (CLcr) < 30 mL/min

Exclusion Criteria:

- All individuals:

- Pregnant or nursing female or male with pregnant female partner

- Hepatitis B virus, hepatitis C virus (HCV) or HIV infection

- History of clinically significant illness or any other medical disorder that may
interfere with the individual's treatment, assessment or compliance with the
protocol

- For individuals with severe renal impairment:

- Anticipated to require dialysis within 90 days of study dosing
We found this trial at
3
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
2549
mi
from 98109
Orlando, FL
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München, 81241
1009
mi
from 98109
München,
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San Antonio, Texas 78215
1786
mi
from 98109
San Antonio, TX
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