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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Antwerp, Belgium
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
Time frame: From predose (before first study drug administration) up to 72 hours post last study drug administration
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
Time frame: From predose (before first study drug administration) up to 24 hours post last study drug administration
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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From screening up to 10 days after the last study drug administration