Open label study to assess relative bioavailability of filgotinib oral mini-tablet versus oral tablet formulation and effect of food on the mini-tablet formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Commercially developed film-coated tablet administered orally
Film-coated mini-tablets administered orally
Altasciences
Montreal, Canada
Maximum observed plasma concentration of filgotinib (Cmax)
Time frame: From Day 1 pre-dose until Day 15
Cmax of GS-829845, major active metabolite
Time frame: From Day 1 pre-dose until Day 15
Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration of filgotinib (AUC0-t)
Time frame: From Day 1 pre-dose until Day 15
AUC0-t of GS-829845, major active metabolite
Time frame: From Day 1 pre-dose until Day 15
Area under the plasma concentration time curve from time zero to infinity of filgotinib (AUC0-inf)
Time frame: From Day 1 pre-dose until Day 15
AUC0-inf of GS-829845, major active metabolite
Time frame: From Day 1 pre-dose until Day 15
Number of participants with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
Time frame: Baseline (Day 1) up to 30 days
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