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 |
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.
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
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