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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03417778
Registration number
NCT03417778
Ethics application status
Date submitted
25/01/2018
Date registered
31/01/2018
Titles & IDs
Public title
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
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Scientific title
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Filgotinib in Subjects With Impaired Hepatic Function
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Secondary ID [1]
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2017-000156-25
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Secondary ID [2]
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GS-US-417-4048
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pharmacokinetic (PK) Parameter: AUClast of Filgotinib
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Assessment method [1]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [1]
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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
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Primary outcome [2]
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PK Parameter: AUClast of GS-829845
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Assessment method [2]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration. GS-829845 is the primary metabolite of filgotinib.
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Timepoint [2]
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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
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Primary outcome [3]
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PK Parameter: AUCinf of Filgotinib
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Assessment method [3]
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AUCinf is defined as the concentration of drug extrapolated to infinite time.
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Timepoint [3]
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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
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Primary outcome [4]
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PK Parameter: AUCinf of GS-829845
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Assessment method [4]
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AUCinf is defined as the concentration of drug extrapolated to infinite time. GS-829845 is the primary metabolite of filgotinib.
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Timepoint [4]
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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
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Primary outcome [5]
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PK Parameter: Cmax of Filgotinib
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Assessment method [5]
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Cmax is defined as the maximum observed concentration of drug.
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Timepoint [5]
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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
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Primary outcome [6]
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PK Parameter: Cmax of GS-829845
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Assessment method [6]
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Cmax is defined as the maximum observed concentration of drug. GS-829845 is the primary metabolite of filgotinib.
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Timepoint [6]
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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
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Secondary outcome [1]
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Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
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Assessment method [1]
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Timepoint [1]
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Day 1 up to Day 31
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Secondary outcome [2]
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Percentage of Participants Who Experienced Graded Laboratory Abnormalities
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Assessment method [2]
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Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
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Timepoint [2]
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Day 1 up to Day 31
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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/
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/08/2018
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Texas
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Country [3]
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Germany
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State/province [3]
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Munich
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Country [4]
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New Zealand
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State/province [4]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Galapagos NV
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03417778
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Trial related presentations / publications
Anderson K, Zheng H, Medzihradsky O, et al. THU0117 PHARMACOKINETICS AND SHORT-TERM SAFETY OF FILGOTINIB, A SELECTIVE JANUS KINASE 1 INHIBITOR, IN SUBJECTS WITH MODERATE HEPATIC IMPAIRMENT. Annals of the Rheumatic Diseases. 2019;78:331.
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/78/NCT03417778/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/78/NCT03417778/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Anderson K, Zheng H, Medzihradsky O, et al. THU011...
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More Details
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Results are available at
https://clinicaltrials.gov/study/NCT03417778