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The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.
During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0634 capsules | Experimental |
| |
| Placebo capsules | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0634 | Drug | GLPG0634 300 mg oral capsules, qd, 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments | From screening up to 10 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) and pharmacodynamics (PD) | To determine the plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters as a measure of PD | From first dose up to 10 days after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Vanhoutte, MD | Lakefront Biotherapeutics NV | Study Director |
| Lien Gheyle, MD | SGS Stuivenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stuivenberg | Antwerp | Antwerp | 2060 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25681059 | Derived | Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z. |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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| GLPG0634 |
| Drug |
GLPG0634 450 mg oral capsules, qd, 10 days |
|
| Placebo | Drug | Placebo oral capsules, qd, 10 days |
|