Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 79
Updated:5/5/2014
Start Date:December 2013
End Date:June 2014
Contact:Gilead Study Team
Email:Karim.Sajwani@gilead.com

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A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment

This study is to evaluate the single-dose pharmacokinetics (PK), safety, and tolerability of
GS-5816 in participants with severe renal impairment using matched healthy participants as a
control group.


Inclusion Criteria:

- General good health with stable chronic kidney disease in Severe Renal Impairment
Group

- Screening labs within defined thresholds

- Creatinine clearance must be < 30 mL/min for Severe Renal Impairment group, and ≥ 90
mL/min for Normal Renal Function group

Exclusion Criteria:

- Females who are pregnant or nursing, or males who have a pregnant partner

- Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV

- History of clinically significant illness (including psychiatric or cardiac) or any
other medical disorder that may interfere with subject treatment and/or adherence to
the protocol
We found this trial at
4
sites
1188
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from 91732
San Antonio, TX
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2321
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from 91732
Miami, FL
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2182
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from 91732
Orlando, FL
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1512
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from 91732
St. Paul, MN
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