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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02002767




Registration number
NCT02002767
Ethics application status
Date submitted
2/12/2013
Date registered
6/12/2013
Date last updated
16/11/2020

Titles & IDs
Public title
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Scientific 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
Secondary ID [1] 0 0
2013-004113-41
Secondary ID [2] 0 0
GS-US-281-1056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Velpatasvir

Experimental: Participants with renal impairment - Participants with severe renal impairment will receive a single dose of velpatasvir.

Active Comparator: Participants with normal renal function - Participants with normal renal function will receive a single dose of velpatasvir.


Treatment: Drugs: Velpatasvir
Velpatasvir 100 mg (2 x 50 mg tablets) administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
PK Parameter of Velpatasvir: AUCinf
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
PK Parameter of Velpatasvir: Cmax
Timepoint [3] 0 0
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 [1] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Timepoint [1] 0 0
First dose date plus 30 days
Secondary outcome [2] 0 0
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Timepoint [2] 0 0
First dose date plus 30 days
Secondary outcome [3] 0 0
Percentage Protein Binding of Velpatasvir
Timepoint [3] 0 0
2 or 3 hours post-dose on Day 1

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/06/2014
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02002767
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02002767