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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02397707




Registration number
NCT02397707
Ethics application status
Date submitted
20/03/2015
Date registered
25/03/2015
Date last updated
17/03/2016

Titles & IDs
Public title
Pharmacokinetics of GS-9857 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-9857

Experimental: Moderate Hepatic Impaired - Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of GS-9857 on Day 1.

Experimental: Severe Hepatic Impaired - Participants with severe hepatic impairment and matched healthy controls will receive a single dose of GS-9857 on Day 1.


Treatment: Drugs: GS-9857
GS-9857 100 mg tablet administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the concentration versus time curve from time zero to the last quantifiable concentration (AUClast) for GS-9857 - AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Timepoint [1] 0 0
Predose 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 on Day 1
Primary outcome [2] 0 0
Area under the concentration-time curve extrapolated to infinite time (AUCinf) for GS-9857 - AUCinf is defined as the concentration of drug extrapolated to infinite time.
Timepoint [2] 0 0
Predose 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 on Day 1
Primary outcome [3] 0 0
Maximum observed plasma concentration (Cmax) of GS-9857
Timepoint [3] 0 0
Predose 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 on Day 1
Secondary outcome [1] 0 0
Safety profile of GS-9857 as measured by incidence of adverse events and laboratory abnormalities
Timepoint [1] 0 0
Up to 45 Days

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
70 Years
Gender
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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose
of GS-9857 in adults with normal and impaired hepatic function. Adults in the healthy control
group will be matched to adults with impaired hepatic function by gender, age (± 10 years),
and body mass index (± 15%).
Trial website
https://clinicaltrials.gov/show/NCT02397707
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Luisa Stamm, 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
Other publications