Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food

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 oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects. Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.

Official Title
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A Randomized, Open-label, Two-way Cross-over Study to Determine the Oral Bioavailability of GLPG1205 After Single-dose Intake in Healthy Male Subjects as a Solid Formulation, With and Without Food

Conditions
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Healthy

Intervention / Treatment
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* Drug: 100 mg GLPG1205


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male, age 18-50 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: 18 Years
Maximum Age: 50 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: 100 mg GLPG1205 fasted<br>Single dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast | Drug: 100 mg GLPG1205<br>* A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg<br>|
| Experimental: 100 mg GLPG1205 fed<br>Single dose of 100 mg GLPG1205 as two capsules of 50 mg exactly 30 minutes after the start of a high-fat, high-calorie breakfast | Drug: 100 mg GLPG1205<br>* A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG1205 in plasma | To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition. | From predose up to 504 hours (Day 22) after study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with adverse events | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of adverse events (AEs) | From screening up to 28 (+/-2) days after last study drug administration | 
| The number of subjects with abnormal laboratory parameters | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal laboratory parameters | From screening up to 28 (+/-2) days after last study drug administration | 
| The number of subjects with abnormal vital signs | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal vital signs | From screening up to 28 (+/-2) days after last study drug administration | 
| The number of subjects with abnormal electrocardiogram (ECG) | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal electrocardiogram (ECG) | From screening up to 28 (+/-2) days after last study drug administration | 
| The number of subjects with abnormal physical examination | To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal physical examination | From screening up to 28 (+/-2) days after last study drug administration |