Back to resultsStudy to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Primary Purpose
Hepatitis C Virus
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Velpatasvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Participants with renal impairment
Participants with normal renal function
Arm Description
Participants with severe renal impairment will receive a single dose of velpatasvir.
Participants with normal renal function will receive a single dose of velpatasvir.
Outcomes
Primary Outcome Measures
Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast
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
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
PK Parameter of Velpatasvir: Cmax
Cmax is defined as the maximum observed plasma concentration of drug.
Secondary Outcome Measures
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02002767
Brief Title
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Official Title
A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 16, 2013 (Actual)
Primary Completion Date
June 9, 2014 (Actual)
Study Completion Date
June 9, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with renal impairment
Arm Type
Experimental
Arm Description
Participants with severe renal impairment will receive a single dose of velpatasvir.
Arm Title
Participants with normal renal function
Arm Type
Active Comparator
Arm Description
Participants with normal renal function will receive a single dose of velpatasvir.
Intervention Type
Drug
Intervention Name(s)
Velpatasvir
Other Intervention Name(s)
GS-5816
Intervention Description
Velpatasvir 100 mg (2 x 50 mg tablets) administered orally
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast
Description
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
Time Frame
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
Title
PK Parameter of Velpatasvir: AUCinf
Description
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
Time Frame
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
Title
PK Parameter of Velpatasvir: Cmax
Description
Cmax is defined as the maximum observed plasma concentration of drug.
Time Frame
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Description
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.
Time Frame
First dose date plus 30 days
Title
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Description
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).
Time Frame
First dose date plus 30 days
Title
Percentage Protein Binding of Velpatasvir
Description
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.
Time Frame
2 or 3 hours post-dose on Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Christchurch
ZIP/Postal Code
08011
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
We'll reach out to this number within 24 hrs