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The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects.
Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | single ascending doses |
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| 2 | Placebo Comparator | single dose placebo |
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| 3 | Experimental | single dose, oral solution, 50 mg |
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| 4 | Experimental | single dose, capsules (fasting) |
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| 5 | Experimental | single dose, capsules (fed) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0492 | Drug | single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single ascending doses in healthy young and elderly subjects. | up to 10 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of single oral doses (solution) in young and elderly subjects. | up to 10 days postdose | |
| Determine oral bioavailability of GLPG0492 given to elderly subjects as oral solution or solid dosage form with or without food. | up to 10 days postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Namour, PhD | Lakefront Biotherapeutics NV | Study Director |
| Sofie Mesens, MD | SGS Stuivenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stuivenberg | Antwerp | Belgium |
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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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| placebo | Drug | single dose, oral solution |
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| GLPG0492 | Drug | single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting |
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| GLPG0492 | Drug | single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast |
|
| Determine the maximum tolerated dose in young subjects. | Up to 10 days postdose |