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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02402452




Registration number
NCT02402452
Ethics application status
Date submitted
25/03/2015
Date registered
30/03/2015
Date last updated
20/03/2020

Titles & IDs
Public title
Pharmacokinetics of Voxilaprevir in Adults 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-9857 in Subjects With Normal Renal Function and Severe Renal Impairment
Secondary ID [1] 0 0
2015-000341-23
Secondary ID [2] 0 0
GS-US-338-1125
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HCV Infection 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
Renal and Urogenital 0 0 0 0
Kidney disease

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

Experimental: Normal Renal Function - Participants will receive a single dose of voxilaprevir on Day 1.

Experimental: Severe Renal Impairment - Participants will receive a single dose of voxilaprevir on Day 1.


Treatment: Drugs: Voxilaprevir
100 mg tablet administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
PK Parameter of Voxilaprevir: AUCinf
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
PK Parameter of Voxilaprevir: Cmax
Timepoint [3] 0 0
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
Secondary outcome [1] 0 0
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities
Timepoint [1] 0 0
First dose date to Day 31

Eligibility
Key inclusion criteria
Key

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

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
5/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2015
Sample size
Target
Accrual to date
Final
20
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
Texas
Country [3] 0 0
Germany
State/province [3] 0 0
München
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 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.
Trial website
https://clinicaltrials.gov/study/NCT02402452
Trial related presentations / publications
Lawitz E, Marbury T, Kirby BJ, Au NT, Mathias A, Stamm LM, Wei H, Sajwani K, Klein G, Gane E, Robson R. The effect of renal or hepatic impairment on the pharmacokinetics of GS-9857, a pangenotypic HCV NS3/4A protease inhibitor. The International Liver Congress; 2016; Barcelona, Spain.
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director, MD, PhD
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/study/NCT02402452