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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02808312




Registration number
NCT02808312
Ethics application status
Date submitted
17/06/2016
Date registered
21/06/2016
Date last updated
30/10/2018

Titles & IDs
Public title
Pharmacokinetics and Pharmacodynamics of GS-9674 in Adults With Normal and Impaired Hepatic Function
Scientific title
A Phase 1 Open-Label, Parallel-Group, Adaptive, Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9674 in Subjects With Normal and Impaired Hepatic Function
Secondary ID [1] 0 0
GS-US-402-3885
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis (NASH) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-9674 (30 mg)
Treatment: Drugs - GS-9674 (10 mg)

Experimental: Mild Hepatic Impairment (Cohort 1) - Participants with mild hepatic impairment and matched healthy controls will receive a single dose of GS-9674 (30 mg) on Day 1.

Experimental: Moderate Hepatic Impairment (Cohort 2) - Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of GS-9674 (30 mg) on Day 1.

Experimental: Severe Hepatic Impairment (Cohort 3) - Participants with severe hepatic impairment and matched healthy controls will receive a single dose of GS-9674 (10 mg) on Day 1.


Treatment: Drugs: GS-9674 (30 mg)
GS-9674 30 mg (3 x 10 mg tablet) orally

Treatment: Drugs: GS-9674 (10 mg)
GS-9674 10 mg (1 x 10 mg tablet) orally

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

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic (PK) Parameter: AUClast of GS-9674 - AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Timepoint [1] 0 0
Predose and up to 96 hours postdose
Primary outcome [2] 0 0
PK Parameter: AUCinf of GS-9674 - AUCinf is defined as the concentration of drug extrapolated to infinite time.
Timepoint [2] 0 0
Predose and up to 96 hours postdose
Primary outcome [3] 0 0
PK Parameter: Cmax of GS-9674 - Cmax is defined as the maximum concentration of drug.
Timepoint [3] 0 0
Predose and up to 96 hours postdose
Primary outcome [4] 0 0
PK Parameter: %AUCexp of GS-9674 - %AUCexp is defined as the percentage of area under the curve (AUC) extrapolated between AUClast and AUCinf.
Timepoint [4] 0 0
Predose and up to 96 hours postdose
Primary outcome [5] 0 0
PK Parameter: Clast of GS-9674 - Clast is defined as the last observable concentration of drug.
Timepoint [5] 0 0
Predose and up to 96 hours postdose
Primary outcome [6] 0 0
PK Parameter: Tmax of GS-9674 - Tmax is defined as the time (observed time point) of Cmax.
Timepoint [6] 0 0
Predose and up to 96 hours postdose
Primary outcome [7] 0 0
PK Parameter: Tlast of GS-9674 - Tlast is defined as the time (observed time point) of Clast.
Timepoint [7] 0 0
Predose and up to 96 hours postdose
Primary outcome [8] 0 0
PK Parameter: ?z of GS-9674 - ?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
Timepoint [8] 0 0
Predose and up to 96 hours postdose
Primary outcome [9] 0 0
PK Parameter: CL/F of GS-9674 - CL/F is defined as the apparent oral clearance following administration of the drug.
Timepoint [9] 0 0
Predose and up to 96 hours postdose
Primary outcome [10] 0 0
PK Parameter: Vz/F of GS-9674 - Vz/F is defined as the apparent volume of distribution of the drug.
Timepoint [10] 0 0
Predose and up to 96 hours postdose
Primary outcome [11] 0 0
PK Parameter: t1/2 of GS-9674 - t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Timepoint [11] 0 0
Predose and up to 96 hours postdose
Secondary outcome [1] 0 0
Incidences of Adverse Events
Timepoint [1] 0 0
Up to 30 days posttreatment
Secondary outcome [2] 0 0
Changes from Baseline in Pharmacodynamic (PD) Markers such as FGF19 and C4
Timepoint [2] 0 0
Predose and up to 96 hours postdose

Eligibility
Key inclusion criteria
Key

Cohort 1:

- Individuals with mildly impaired and normal hepatic function.

- Individuals with mild hepatic impairment must have a score of 5-6 on the CPT
Classification at Screening without evidence of worsening clinical and/or laboratory
signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 2:

- Individuals with moderately impaired and normal hepatic function.

- Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT
Classification at Screening without evidence of worsening clinical and/or laboratory
signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 3:

- Individuals with severely impaired and normal hepatic function.

- Individuals with severe hepatic impairment must have a score of 10-15 on the CPT
Classification at Screening without evidence of worsening clinical and/or laboratory
signs of hepatic impairment within 2 months prior or within the screening period.

Note: Other protocol defined Inclusion/
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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
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
Tennessee
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
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 single-dose pharmacokinetics of
GS-9674 in adults with impaired hepatic function relative to matched, healthy controls with
normal hepatic function.
Trial website
https://clinicaltrials.gov/show/NCT02808312
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
Other publications