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The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.
Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0634 capsule fasted | Experimental | Single dose of GLPG0634 as capsules in fasted condition |
|
| GLPG0634 tablet fasted | Experimental | Single dose of GLPG0634 as tablets in fasted condition |
|
| GLPG0634 tablet fed | Active Comparator | Single dose of GLPG0634 as tablets in fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 200 mg GLPG0634 as capsules, fasted | Drug | single oral dose of 200 mg GLPG0634 given as capsules in fasted condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets | To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition. | From predose (before first study drug administration) up to 144 hours post last study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets | To evaluate the safety and tolerability of GLPG0634 after a single oral dose as capsules or tablets, either fasted or fed, in male healthy subjects in terms of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs and electrocardiogram (ECG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pille Harrison, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS LSS Clinical Pharmacology Unit Antwerp | Antwerp | Antwerp | Belgium |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
| D002214 | Capsules |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| 200 mg GLPG0634 as tablets, fasted | Drug | single oral dose of 200 mg GLPG0634 given as tablets in fasted condition |
|
| 200 mg GLPG0634 as tablets, fed | Drug | single oral dose of 200 mg GLPG0634 given as tablets in fed condition |
|
| Between screening and 7-10 days after the last dose |