Oral Bioavailability of Two Solid Formulations of GLPG0634

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 (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects. Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.

Official Title
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Bioavailability Study Comparing Two Solid Oral Formulations of GLPG0634 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: 200 mg GLPG0634 as capsules, fasted
* Drug: 200 mg GLPG0634 as tablets, fasted
* Drug: 200 mg GLPG0634 as tablets, fed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male, age 40-60 years 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
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG0634 capsule fasted<br>Single dose of GLPG0634 as capsules in fasted condition | Drug: 200 mg GLPG0634 as capsules, fasted<br>* single oral dose of 200 mg GLPG0634 given as capsules in fasted condition<br>|
| Experimental: GLPG0634 tablet fasted<br>Single dose of GLPG0634 as tablets in fasted condition | Drug: 200 mg GLPG0634 as tablets, fasted<br>* single oral dose of 200 mg GLPG0634 given as tablets in fasted condition<br>|
| Active Comparator: GLPG0634 tablet fed<br>Single dose of GLPG0634 as tablets in fed condition | Drug: 200 mg GLPG0634 as tablets, fed<br>* single oral dose of 200 mg GLPG0634 given as tablets in fed condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets | To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition. | From predose (before first study drug administration) up to 144 hours post last study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets | To evaluate the safety and tolerability of GLPG0634 after a single oral dose as capsules or tablets, either fasted or fed, in male healthy subjects in terms of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs and electrocardiogram (ECG) | Between screening and 7-10 days after the last dose |