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The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0555 compared to placebo.
Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | single ascending doses |
|
| 2 | Placebo Comparator | single dose placebo |
|
| 3 | Experimental | multiple dose, 7 or 14 days, oral solution |
|
| 4 | Placebo Comparator | multiple dose, 7 or 14 days, oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0555 | Drug | single ascending doses, oral solution |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single and multiple dosing | up to 10 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of single and repeated doses, including effect of food. | up to 10 days postdose | |
| To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration | up to 72 hours 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 |
| Wouter Haazen, MD | SGS Stuivenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stuivenberg | Antwerp | Belgium |
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| Drug |
single dose, oral solution |
|
| GLPG0555 | Drug | multiple dose, oral solution, 7 or 14 days |
|
| placebo | Drug | multiple dose, oral solution, 7 or 14 days |
|