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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004408-21 | EudraCT Number |
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The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects.
Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0634 in Japanese subjects | Experimental | Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days |
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| Placebo in Japanese healthy subjects | Placebo Comparator | Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days |
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| GLPG0634 in Caucasian subjects | Experimental | In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days |
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| Placebo in Caucasian healthy subjects | Placebo Comparator | In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0634 50 mg | Drug | 2 tablets of 25 mg GLPG0634 once daily for 10 days |
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| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with adverse events | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of adverse events (AEs) | From screening up to 10 days after last dose (Day 20) |
| The number of subjects with abnormal laboratory parameters | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal laboratory parameters | From screening up to 10 days after last dose (Day 20) |
| The number of subjects with abnormal vital signs | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal vital signs | From screening up to 10 days after last dose (Day 20) |
| The number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal electrocardiogram | From screening up to 10 days after last dose (Day 20) |
| The number of subjects with abnormal physical examination | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal physical examination |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of GLPG0634 mechanism-of-action-related biomarkers in blood | To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested | Between Day 1 before dosing and Day 11 (24 hours after last dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pille Harrison, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research (HMR) | London | United Kingdom |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| GLPG0634 100 mg | Drug | 1 tablet of 100 mg GLPG0634 once daily for 10 days |
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| GLPG0634 200 mg | Drug | 2 tablets of 100 mg GLPG0634 once daily for 10 days |
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| Placebo | Drug | 1 or 2 matching placebo tablets once daily for 10 days |
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| From screening up to 10 days after last dose (Day 20) |
| The amount of GLPG0634 and metabolite in plasma and urine | To characterize the amount of GLPG0634 and metabolite in plasma and urine over time - pharmacokinetics (PK) - in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested Safety Issue?: No | Between Day 1 before dosing and Day 13 (72 hours after last dose) |