Healthy
Conditions
Brief summary
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.
Interventions
DRUGGLPG0634 100mg capsule once a day for 10 days
Sponsors
Galapagos NV
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female, age 40 years and older * BMI between 18-30 kg/m2
Exclusion criteria
* Any condition that might interfere with the procedures or tests in this study * Drug or alcohol abuse * Smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634 | From predose (before first study drug administration) up to 72 hours post last study drug administration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | From screening up to 10 days after the last study drug administration | 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 |
| Changes in vital signs as measured by heart rate, blood pressure and body temperature | From screening up to 10 days after the last study drug administration | 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 |
| Changes in 12-lead ECG measures | From screening up to 10 days after the last study drug administration | 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 |
| The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634 | From predose (before first study drug administration) up to 24 hours post last study drug administration | 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 |
| Changes in blood safety lab parameters | From screening up to 10 days after the last study drug administration | 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 |
| Changes in urine safety lab parameters | From screening up to 10 days after the last study drug administration | 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 |
| Changes in physical exam measures | From screening up to 10 days after the last study drug administration | 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 |
Countries
Belgium
Outcome results
None listed