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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: | Active Comparator | filgotinib administered under fasting conditions |
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| Treatment B: | Experimental | filgotinib administered under fasting conditions |
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| Treatment C: | Experimental | filgotinib administered under high-fat fed conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Commercially developed film-coated tablet administered orally |
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| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Galapagos Study Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences | Montreal | H3P 3P1 | Canada |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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| Filgotinib | Drug | Film-coated mini-tablets administered orally |
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