Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects. Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and dose proportionality of the best formulation. Furthermore, during the course of the study, safety and tolerability will be characterized.

Official Title
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Bioavailability Study of Two Formulations of the Isopropyl Malonate Prodrug of GLPG0187 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG0187 prodrug


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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1: formulation 1 oral solution<br> | Drug: GLPG0187 prodrug<br> <br> |
| Experimental: Period 2: formulation 2 capsule<br> | Drug: GLPG0187 prodrug<br> <br> |
| Experimental: Period 3: Selected formulation + food<br> | Drug: GLPG0187 prodrug<br> <br> |
| Experimental: Period 4: Selected formulation at higher dose<br> | Drug: GLPG0187 prodrug<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug | To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of either of 2 formulations of GLPG0187 prodrug in healthy subjects |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food | To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of the selected formulation of GLPG0187 prodrug with food in healthy subjects |  | 
| The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food) | To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of the selected formulation of GLPG0187 prodrug at a higher dose (with or without food) in healthy subjects to evaluate dose proportionality |  | 
| Number of adverse events | To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of the number of adverse events reported |  | 
| Changes in vital signs as measured by heart rate, blood pressure and body temperature | To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in vital signs as measured by heart rate, blood pressure and body temperature reported |  | 
| Changes on 12-lead ECG measures | To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in 12-ECG measures reported |  | 
| Changes in physical exam measures | To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in physical examination reported |  | 
| Changes in blood and urine safety lab parameters | To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of the changes in blood and urine safety lab parameters assessed |  |