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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004156-21 | 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 GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 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 GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized.
The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well.
During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1972 single dose | Experimental | Single oral dose of GLPG1972 solution - ascending doses |
|
| Placebo single dose | Placebo Comparator | Single oral dose of placebo solution |
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| GLPG1972 multiple doses | Experimental | Multiple oral doses of GLPG1972 solution - ascending doses |
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| Placebo multiple doses | Placebo Comparator | Multiple oral doses of placebo solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1972 single ascending doses | Drug | single dose, oral solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change versus placebo in number of subjects with adverse events | To evaluate the safety and tolerability of GLPG1972 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 |
| Change versus placebo in number of subjects with abnormal laboratory parameters | To evaluate the safety and tolerability of GLPG1972 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 |
| Change versus placebo in number of subjects with abnormal vital signs | To evaluate the safety and tolerability of GLPG1972 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 |
| Change versus placebo in number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of GLPG1972 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 |
| Change versus placebo in number of subjects with abnormal physical examination | To evaluate the safety and tolerability of GLPG1972 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 GLPG1972 in plasma | To characterize the amount of GLPG1972 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 GLPG1972 in urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ennis Lee, 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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| Placebo single dose |
| Drug |
single dose, oral solution, matching placebo |
|
| GLPG1972 multiple ascending doses | Drug | multiple doses, daily for 14 days, oral solution |
|
| Placebo multiple doses | Drug | multiple doses, daily for 14 days, oral solution |
|
To characterize the amount of GLPG1972 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 interaction after repeated oral dosing with GLPG1972 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine | Twelve hours before dosing on Day 1 and Day 14 |
| Levels of GLPG1972 biomarker in blood | To assess the pharmacodynamics (PD) of GLPG1972 by means of reduction of levels of biomarker in blood by GLPG1972 compared to placebo after repeated oral dosing | Between Day 1 predose and 48 hours after the last dose |