Clinical trial NCT06043739: Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects
Official title: A Randomized, Open-label, 3-period, Single-dose, Cross-over Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Filgotinib Given as an Oral Mini-tablet Formulation Versus the Oral Tablet Formulation of Filgotinib and to Assess the Effect of Food on the Oral Mini-tablet Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

* A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN) and total bilirubin not greater than ULN. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.

Key Exclusion Criteria:

* Known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
* Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.

Primary outcomes:
measure: Maximum observed plasma concentration of filgotinib (Cmax)
timeFrame: From Day 1 pre-dose until Day 15
measure: Cmax of GS-829845, major active metabolite
timeFrame: From Day 1 pre-dose until Day 15
measure: Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration of filgotinib (AUC0-t)
timeFrame: From Day 1 pre-dose until Day 15
measure: AUC0-t of GS-829845, major active metabolite
timeFrame: From Day 1 pre-dose until Day 15
measure: Area under the plasma concentration time curve from time zero to infinity of filgotinib (AUC0-inf)
timeFrame: From Day 1 pre-dose until Day 15
measure: AUC0-inf of GS-829845, major active metabolite
timeFrame: From Day 1 pre-dose until Day 15
Secondary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
timeFrame: Baseline (Day 1) up to 30 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Altasciences
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director
role: STUDY_DIRECTOR
References: