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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/NCT02397707




Registration number
NCT02397707
Ethics application status
Date submitted
20/03/2015
Date registered
25/03/2015
Date last updated
9/04/2020

Titles & IDs
Public title
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Scientific title
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Secondary ID [1] 0 0
2015-000342-30
Secondary ID [2] 0 0
GS-US-338-1126
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

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

Experimental: Moderate Hepatic Impaired - Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.

Experimental: Severe Hepatic Impaired - Participants with severe hepatic impairment and matched healthy controls 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 (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 post-dose
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

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 moderate hepatic impairment:

- Diagnosis of chronic (> 6 months) hepatic impairment

- Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh
Class B).

- For individuals with severe hepatic impairment:

- Diagnosis of chronic (> 6 months) hepatic impairment

- Score on the CPT scale of 10-15 at screening (Child Pugh Class C)

- For individuals with normal hepatic function:

- Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative

Key
Minimum age
18 Years
Maximum age
70 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

- 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 moderate or severe hepatic impairment:

- Active HCV infection

- Current hepatic encephalopathy

- Variceal bleeding in the last 6 months unless banded

- Prior placement of a portosystemic shunt

- History of hepatorenal or hepatopulmonary syndrome

- Spontaneous bacterial peritonitis currently or within the last 6 months

- Hospitalization within the last 2 months related to cirrhosis

- Confirmed hypotension

- Suspicion of hepatocellular carcinoma

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
24/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/03/2016
Sample size
Target
Accrual to date
Final
33
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
Auckland

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 (PK), safety, and
tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal
hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in
the healthy control group will be matched to participants with impaired hepatic function by
gender, age (± 10 years), and body mass index (± 15%).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02397707
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