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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004771-12 | EudraCT Number |
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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 oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects.
Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg GLPG1205 fasted | Experimental | Single dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast |
|
| 100 mg GLPG1205 fed | Experimental | Single dose of 100 mg GLPG1205 as two capsules of 50 mg exactly 30 minutes after the start of a high-fat, high-calorie breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg GLPG1205 | Drug | A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| The amount of GLPG1205 in plasma | To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition. | From predose up to 504 hours (Day 22) after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with adverse events | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of adverse events (AEs) | From screening up to 28 (+/-2) days after last study drug administration |
| The number of subjects with abnormal laboratory parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Vanhoutte, 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 |
|---|---|
| C000722907 | GLPG1205 |
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To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal laboratory parameters |
| From screening up to 28 (+/-2) days after last study drug administration |
| The number of subjects with abnormal vital signs | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal vital signs | From screening up to 28 (+/-2) days after last study drug administration |
| The number of subjects with abnormal electrocardiogram (ECG) | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal electrocardiogram (ECG) | From screening up to 28 (+/-2) days after last study drug administration |
| The number of subjects with abnormal physical examination | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal physical examination | From screening up to 28 (+/-2) days after last study drug administration |