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This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet relative to an oral solution and to the oral direct compression (DC) tablet after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the WG oral tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | GLPG1972 oral solution after overnight fast |
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| Treatment B | Experimental | GLPG1972 oral DC tablet after breakfast |
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| Treatment C | Experimental | GLPG1972 oral WG tablet after overnight fast |
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| Treatment D | Experimental | GLPG1972 oral WG tablet after breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1972 | Drug | Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the maximum observed plasma concentration of GLPG1972 after single oral doses | Determine bioavailability of GLPG1972 by assessing PK parameters | on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses |
| Assessment of plasma concentration of GLPG1972 24hrs post-dose after single oral doses | Determine bioavailability of GLPG1972 by assessing PK parameters | At 24 hours post dose |
| Assessment of time to achieve the maximal plasma concentration of GLPG1972 after single oral doses | Determine bioavailability of GLPG1972 by assessing PK parameters | on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses |
| Assessment of the last quantifiable plasma concentration of GLPG1972 after single oral doses | Determine bioavailability of GLPG1972 by assessing PK parameters | on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses |
| Measure | Description | Time Frame |
|---|---|---|
| the number of subjects with adverse events | To assess safety and tolerability of GLPG1972 given orally | at screening, pre-dose at date 1 and post-dose at 24 and 48 hours |
| the number of subjects with abnormal vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Fieuw, MD MSc | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium Life Sciences | Antwerp | Belgium |
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To assess safety and tolerability of GLPG1972 given orally
| at screening, pre-dose at date 1 and post-dose at 24 and 48 hours |
| the number of subjects with abnormal ECG | To assess safety and tolerability of GLPG1972 given orally | at screening, pre-dose at date 1 and post-dose at 24 and 48 hours |
| the number of subjects with abnormal laboratory assessments | To assess safety and tolerability of GLPG1972 given orally | at screening, pre-dose at date 1 and post-dose at 24 and 48 hours |