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This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | GLPG1690 oral capsules after breakfast |
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| Treatment B | Experimental | GLPG1690 oral tablets after breakfast |
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| Treatment C | Experimental | GLPG1690 oral tablets after overnight fast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1690 | Drug | Oral administration of GLPG1690 in three different treatment conditions (treatment A through C) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the maximum observed plasma concentration of GLPG1690 after single oral doses | Determine the bioavailability of GLPG1690 by assessing PK parameters | predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing |
| Assessment of the time to reach the maximum observed plasma concentration of GLPG1690 after single oral doses | Determine the bioavialability of GLPG1690 by assessing PK parameters | predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing |
| Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses | Determine the bioavialability of GLPG1690 by assessing PK parameters | predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with adverse events | To assess safety and tolerability of GLPG1690 | Throughout the study from screening until the follow up visit (day 7 of dosing period 3) |
| 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 CPU | Antwerp | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31012984 | Derived | van der Aar E, Desrivot J, Dupont S, Heckmann B, Fieuw A, Stutvoet S, Fagard L, Van de Wal K, Helmer E. Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials. J Clin Pharmacol. 2019 Oct;59(10):1366-1378. doi: 10.1002/jcph.1424. Epub 2019 Apr 23. |
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| ID | Term |
|---|---|
| C000621178 | GLPG1690 |
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To assess safety and tolerability of GLPG1690
| Throughout the study from screening until the follow up visit (day 7 of dosing period 3) |
| The number of subjects with abnormal ECG | To assess safety and tolerability of GLPG1690 | Throughout the study from screening until the follow up visit (day 7 of dosing period 3) |
| The number of subjects with abnormal physical examination | To assess safety and tolerability of GLPG1690 | Throughout the study from screening until the follow up visit (day 7 of dosing period 3) |
| The number of subjects with abnormal laboratory analysis | To assess safety and tolerability of GLPG1690 | Throughout the study from screening until the follow up visit (day 7 of dosing period 3) |