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 |
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.
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
Orlando, Florida 32806
407-240-7878
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