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The purpose of the study is to evaluate the amount of compound present in the blood (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy subjects.
During the course of the study, the effect of aging on the pharmacokinetics as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy subjects will be characterized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40-50 years old | Experimental | GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old |
|
| 65-74 years old | Experimental | GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old |
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| 75 years and older | Experimental | GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0634 100mg capsule once a day for 10 days | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634 | To characterize the amount of GLPG0634 in plasma over time - pharmacokinetics (PK) - after single and multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging | From predose (before first study drug administration) up to 72 hours post last study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634 | To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - after multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging | From predose (before first study drug administration) up to 24 hours post last study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Vanhoutte, MD | Lakefront Biotherapeutics NV | Study Director |
| Magdalena Petkova, MD | SGS LSS Clinical Pharmacology Unit Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS LSS Clinical Pharmacology Unit Antwerp | Antwerp | Antwerp | 2060 | Belgium |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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| Number of adverse events | To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of the number of adverse events reported | From screening up to 10 days after the last study drug administration |
| Changes in vital signs as measured by heart rate, blood pressure and body temperature | To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in vital signs as measured by heart rate, blood pressure and body temperature reported | From screening up to 10 days after the last study drug administration |
| Changes in 12-lead ECG measures | To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in 12-ECG measures reported | From screening up to 10 days after the last study drug administration |
| Changes in physical exam measures | To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in physical examination reported | From screening up to 10 days after the last study drug administration |
| Changes in blood safety lab parameters | To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in blood safety lab parameters assessed | From screening up to 10 days after the last study drug administration |
| Changes in urine safety lab parameters | To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in urine safety lab parameters assessed | From screening up to 10 days after the last study drug administration |