Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG0634 100mg capsule once a day for 10 days


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 40-50 years old<br>GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old | Drug: GLPG0634 100mg capsule once a day for 10 days<br> <br> |
| Experimental: 65-74 years old<br>GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old | Drug: GLPG0634 100mg capsule once a day for 10 days<br> <br> |
| Experimental: 75 years and older<br>GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older | Drug: GLPG0634 100mg capsule once a day for 10 days<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |