Phase 1
Completed N=20
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment
HCV Infection
Source: ClinicalTrials.gov NCT02402452 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast — 662.7; 383.3 h*ng/mL
Summary
The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast |
662.7; 383.3 | — |
| PRIMARY PK Parameter of Voxilaprevir: AUCinf |
772.1; 450.8 | — |
| PRIMARY PK Parameter of Voxilaprevir: Cmax |
49.2; 33.9 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities |
20; 50; 70; 30 | — |
Eligibility Criteria
Key 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
Key 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02402452). 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. Informational only — not medical advice.