Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bioavailability

Intervention / Treatment
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* Drug: Filgotinib
* Drug: Filgotinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A:<br>filgotinib administered under fasting conditions | Drug: Filgotinib<br>* Commercially developed film-coated tablet administered orally<br>* Other names: Jyseleca;|
| Experimental: Treatment B:<br>filgotinib administered under fasting conditions | Drug: Filgotinib<br>* Film-coated mini-tablets administered orally<br>* Other names: GLPG0634;|
| Experimental: Treatment C:<br>filgotinib administered under high-fat fed conditions | Drug: Filgotinib<br>* Film-coated mini-tablets administered orally<br>* Other names: GLPG0634;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration of filgotinib (Cmax) |  | From Day 1 pre-dose until Day 15 | 
| Cmax of GS-829845, major active metabolite |  | 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) |  | From Day 1 pre-dose until Day 15 | 
| AUC0-t of GS-829845, major active metabolite |  | 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 | 
| AUC0-inf of GS-829845, major active metabolite |  | From Day 1 pre-dose until Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |