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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022457-42 | EudraCT Number |
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The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0555 solid dispersion, fasting | Experimental | 50 mg as solid dispersion capsule, in fasting condition |
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| GLPG0555 solid dispersion, fed | Experimental | 50 mg as solid dispersion capsule, after breakfast |
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| GLPG0555 nanosuspension, fed | Experimental | 50 mg as nanosuspension, given after breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0555 solid dispersion | Drug | solid dispersion capsules, 50 mg, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability of solid formulation | 72 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single doses of GLPG0555 | up to 10 days postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerben van 't Klooster, PhD | Lakefront Biotherapeutics NV | Study Director |
| Jos Leempoels, MD | SGS Stuivenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stuivenberg | Antwerp | 2060 | Belgium |
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| GLPG0555 nanosuspension | Drug | Nanosuspension, 50 mg, single dose |
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