Phase 1
N=19
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Hepatitis C Virus
Bottom Line
View on ClinicalTrials.gov: NCT02002767 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast — 5597.8; 7971.7 h*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Velpatasvir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast |
5597.8; 7971.7 | — |
| PRIMARY PK Parameter of Velpatasvir: AUCinf |
5651.6; 8108.3 | — |
| PRIMARY PK Parameter of Velpatasvir: Cmax |
702.7; 732.4 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
0; 20 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities |
33.3; 20; 0; 30; 0; 30 | — |
| SECONDARY Percentage Protein Binding of Velpatasvir |
0.29; 0.29; 99.71; 99.71 | — |
Summary
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.
Eligibility Criteria
Key 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
Key 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 participant treatment and/or adherence to the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02002767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.