Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
- Registration Number
- NCT02002767
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants with renal impairment Velpatasvir Participants with severe renal impairment will receive a single dose of velpatasvir. Participants with normal renal function Velpatasvir Participants with normal renal function will receive a single dose of velpatasvir.
- Primary Outcome Measures
Name Time Method Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1 AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
PK Parameter of Velpatasvir: AUCinf Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1 AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
PK Parameter of Velpatasvir: Cmax Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1 Cmax is defined as the maximum observed plasma concentration of drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing Treatment-Emergent Adverse Events First dose date plus 30 days Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities First dose date plus 30 days A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening).
Percentage Protein Binding of Velpatasvir 2 or 3 hours post-dose on Day 1 Mean velpatasvir protein binding (percentage free and percentage bound) was determined in all participants at 2 or 3 hours post-dose. Protein binding was assessed at Tmax whenever possible or at the time point closest to Tmax for each participant.