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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Normal Renal Function
Participants will receive a single dose of voxilaprevir on Day 1.
Intervention: Voxilaprevir (Drug)
Severe Renal Impairment
Participants will receive a single dose of voxilaprevir on Day 1.
Intervention: Voxilaprevir (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
Time Frame: 0 (predose ≤ 5 min) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.
PK Parameter of Voxilaprevir: AUCinf
Time Frame: 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.
PK Parameter of Voxilaprevir: Cmax
Time Frame: 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals.
Secondary Outcomes
- Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities(First dose date to Day 31)