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The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects.
Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG0974 oral solution | Experimental | GLPG0974 oral solution |
|
| Placebo oral solution | Placebo Comparator | Placebo oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0974 | Drug |
| ||
| GLPG0974 |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of GLPG0974 in plasma over time after a single oral dose | To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments | |
| Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Vanhoutte, MD | Lakefront Biotherapeutics NV | Study Director |
| Wouter Haazen, MD | SGS Stuivenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stuivenberg | Antwerp | Antwerp | Belgium |
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| ID | Term |
|---|---|
| C000595478 | 4-(((R)-1-(benzo(b)thiophene-3-carbonyl)-2-methyl-azetidine-2-carbonyl)-(3-chloro-benzyl)-amino)-butyric acid |
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|
To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after a single oral dose in healthy subjects |