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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03417778




Registration number
NCT03417778
Ethics application status
Date submitted
25/01/2018
Date registered
31/01/2018
Date last updated
16/10/2018

Titles & IDs
Public title
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
Scientific title
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Filgotinib in Subjects With Impaired Hepatic Function
Secondary ID [1] 0 0
2017-000156-25
Secondary ID [2] 0 0
GS-US-417-4048
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Ulcerative Colitis 0 0
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

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

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

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

Experimental: Mild Hepatic Impairment - Participants with mild hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1.


Treatment: Drugs: Filgotinib
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 Filgotinib and GS-829845 - AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Timepoint [1] 0 0
Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 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 Filgotinib and GS-829845 - AUCinf is defined as the concentration of drug extrapolated to infinite time.
Timepoint [2] 0 0
Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1
Primary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax) for Filgotinib and GS-829845. - Cmax is maximum observed concentration of drug in plasma
Timepoint [3] 0 0
Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1
Secondary outcome [1] 0 0
Proportion of Participants Experiencing Adverse Events
Timepoint [1] 0 0
Up to 31 days
Secondary outcome [2] 0 0
Proportion of Participants with Graded Clinical Chemistry or Hematology Laboratory Abnormalities
Timepoint [2] 0 0
Up to 31 days

Eligibility
Key inclusion criteria
Key

- Eligible individuals will be male and nonpregnant, nonlactating females, aged 18 to 70
years (inclusive), body mass index (BMI) between 18 and 36 kg/m^2 (inclusive), with
either impaired hepatic function or normal hepatic function.

- Individuals will be current nonsmokers (no use of tobacco, nicotine-containing, or
tetrahydrocannabinol (THC)-containing products within the last 14 days).

- Individuals with hepatic impairment will be categorized by the Child-Pugh-Turcotte
(CPT) classification system indicating hepatic impairment as follows:

- Class A (mild): CPT score 5-6

- Class B (moderate): CPT score 7-9

- Class C (severe): CPT score 10-15

- Hepatic impairment must have been stable during the 3 months (90 days) prior to study
drug. Each individual in the control group will be matched to a individual with
impaired hepatic function by age (± 10 years), gender, and body mass index (± 15%).

Note: Other protocol defined Inclusion/
Minimum age
18 Years
Maximum age
70 Years
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
Texas
Country [3] 0 0
Germany
State/province [3] 0 0
Munich
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
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Galapagos NV
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib
and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic
function relative to matched, healthy controls.
Trial website
https://clinicaltrials.gov/show/NCT03417778
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