At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Filgotinibdrug
Likely dose
Filgotinib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Filgotinib in Subjects With Impaired Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Filgotinib for Rheumatoid Arthritis. Completed, enrolled 20 participants across 4 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesGermany, New Zealand, United States
CollaboratorsLakefront Biotherapeutics NV
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartApr 2018
Primary CompletionAug 2018
TodayJul 2026
First PostedJan 31, 2018
Enrollment StartApr 3, 2018
Primary CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.4 years ago
Interventions
Filgotinibdrug
100 mg tablet administered orally