A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Film-coated mini-tablets administered orally once daily
Commercially developed film-coated tablet administered orally once daily
CHU Amiens - Hopital Nord
Amiens, France
RECRUITINGBicêtre University Hospital
Le Kremlin-Bicêtre, France
RECRUITINGMaximum observed plasma concentration at steady state of filgotinib (Cmax,ss)
Time frame: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Cmax,ss of GS-829845, major active metabolite
Time frame: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Area under the plasma concentration-time curve over the dosing interval at steady state of filgotinib (AUC0-24,ss)
Time frame: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
AUC0-24,ss of GS-829845, major active metabolite
Time frame: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Area under the plasma concentration time curve over the dosing interval at steady state or the effective exposure of filgotinib (AUCeff,ss)
Time frame: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
AUCeff,ss of GS-829845, major active metabolite
Time frame: Pre-dose on Day 10, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours post-dose on Day 10
Number of participants with treatment-emergent adverse events (TEAEs), TEAEs of interest, serious TEAEs, and TEAEs leading to treatment discontinuation.
Time frame: Baseline (Day 1) up to week 96
Acceptability of the commercially developed film-coated tablets and of the minitablets as measured by the Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P).
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Children's university hospital Charité, Campus Virchow, SPZ
Berlin, Germany
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg, Germany
RECRUITINGAsklepios Klinik Sankt Augustin GmbH
Sankt Augustin, Germany
NOT_YET_RECRUITINGMalopolskie Badania Kliniczne
Krakow, Poland
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGHospital Sant Joan de Deu
Barcelona, Spain
RECRUITINGHospital Universitari i Politecnic La Fe
Valencia, Spain
RECRUITINGGreat Ormond Street Hospital
London, United Kingdom
NOT_YET_RECRUITINGTime frame: Week 4 and week 12