Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects
- Registration Number
- NCT06043739
- Lead Sponsor
- Galapagos NV
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C: Filgotinib filgotinib administered under high-fat fed conditions Treatment A: Filgotinib filgotinib administered under fasting conditions Treatment B: Filgotinib filgotinib administered under fasting conditions
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration of filgotinib (AUC0-t) From Day 1 pre-dose until Day 15 Area under the plasma concentration time curve from time zero to infinity of filgotinib (AUC0-inf) From Day 1 pre-dose until Day 15 Maximum observed plasma concentration of filgotinib (Cmax) From Day 1 pre-dose until Day 15 AUC0-t of GS-829845, major active metabolite From Day 1 pre-dose until Day 15 Cmax of GS-829845, major active metabolite From Day 1 pre-dose until Day 15 AUC0-inf of GS-829845, major active metabolite From Day 1 pre-dose until Day 15
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations Baseline (Day 1) up to 30 days
Trial Locations
- Locations (1)
Altasciences
🇨🇦Montréal, Canada