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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004466-29 | 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 GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.
The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG2222 single dose | Experimental | Single dose of GLPG2222 oral suspension |
|
| Placebo single dose | Placebo Comparator | Single dose of placebo oral suspension |
|
| GLPG2222 multiple doses | Experimental | Multiple doses of GLPG2222 oral suspension |
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| Placebo multiple doses | Placebo Comparator | Multiple doses of placebo oral suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG2222 single dose | Drug | single ascending doses, oral suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change versus placebo in number of subjects with adverse events | To evaluate the safety and tolerability of GLPG2222 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 GLPG2222 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 GLPG2222 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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram | 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 GLPG2222 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 |
| Change versus placebo in number of subjects with abnormal pulmonary function |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of GLPG2222 in plasma | To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects | Between Day 1 predose and 48 hours after the (last) dose |
| The amount of GLPG2222 in urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsteen Donaldson, 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 |
|---|---|
| C000708865 | GLPG2222 |
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| Placebo single dose |
| Drug |
single doses, oral suspension, matching placebo |
|
| GLPG2222 multiple doses | Drug | multiple ascending doses, daily for 14 days, oral suspension |
|
| Placebo multiple doses | Drug | multiple doses, daily for 14 days, oral suspension, matching placebo |
|
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry |
| Between screening and 4 days after the last dose (Part 1 only) |
To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects |
| 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 GLPG2222 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine | Twelve hours before dosing on Day 1 and Day 14 |