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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024039-18 | EudraCT Number |
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The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple oral administrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0492 oral solution | Experimental | Multiple ascending doses once daily for 14 days, starting from 5 mg/day |
|
| Placebo oral solution | Placebo Comparator | Once daily dosing for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0492 | Drug | Oral solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo | Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability | Up to 2 weeks after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetic profile and metabolism after single and multiple doses of GLPG0492 | The plasma levels of GLPG0492 will be determined as a measure of pharmacokinetics, and the plasma and urine levels of GLPG0492 will be used for metabolism investigation | Up to 2h hours after last treatment |
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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 |
|---|---|---|---|---|---|---|
| Parexel Early Phase Clinical Unit | Berlin | 14050 | Germany |
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| ID | Term |
|---|---|
| C577110 | 4-(4-(hydroxymethyl)-3-methyl-2,5-dioxo-4-phenylimidazolidin-1-yl)-2-(trifluoromethyl)benzonitrile |
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| Drug |
Oral solution |
|
| To assess whether GLPG0492 induces CYP450, a pharmacodynamic marker by measuring the ratio of β-OH-cortisol /cortisol in urine |
To assess the potential of daily doses of GLPG0492 to induce cytochrome P450(CYP3A4), a pharmacodynamic marker, by measurement of the ratio of β-OH-cortisol /cortisol in urine |
| Up to 24 hours after last treatment |