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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003853-32 | EudraCT Number |
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The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated.
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized.
The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated.
The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1837 single dose | Experimental | Single oral dose of GLPG1837 suspension - ascending doses |
|
| Placebo single dose | Placebo Comparator | Single oral dose of placebo suspension |
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| GLPG1837 muliple doses | Experimental | Multiple oral doses of GLPG1837 suspension - ascending doses |
|
| Placebo multiple doses | Placebo Comparator | Multiple oral doses of placebo suspension |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1837 single ascending doses | Drug | Single dose, oral suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events | Between screening and 7-10 days after the last dose |
| Number of subjects with abnormal laboratory parameters | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters | Between screening and 7-10 days after the last dose |
| Number of subjects with abnormal vital signs | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs | Between screening and 7-10 days after the last dose |
| Number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms | Between screening and 7-10 days after the last dose |
| Number of subjects with abnormal physical examination | To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination | Between screening and 7-10 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of GLPG1837 and its metabolite in plasma | To characterize the amount of GLPG1837 and its metabolite in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed | Between Day 1 predose and 48 hours after the (last) dose |
| The amount of GLPG1837 and its metabolite in urine |
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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 | Belgium |
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| Placebo single dose |
| Drug |
Single dose, oral suspension matching placebo |
|
| GLPG1837 multiple ascending doses | Drug | Multiple doses, daily for 14 days, oral suspension |
|
| Placebo multiple doses | Drug | Multiple doses, daily for 14 days, oral suspension, matching placebo |
|
To characterize the amount of GLPG1837 and its metabolite in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed |
| Between Day 1 predose and 24 hours after the (last) dose |
| Ratio of 6-b-hydroxycortisol/cortisol in urine | To assess the potential of CYP3A4 induction after repeated oral dosing with GLPG1837 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine | Twelve hours before dosing on Day 1 and Day 14 |