Oral Bioavailability of Solid Formulation of GLPG1837 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 GLPG1837 and metabolite present in the blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, in male healthy subjects. Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, will be assessed. Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be separated by a wash-out period of at least 6 days.

Official Title
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An Open-label Study to Compare the Oral Bioavailability of an Oral Tablet of GLPG1837 Relative to an Oral Suspension After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Oral Tablet

Conditions
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Healthy

Intervention / Treatment
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* Drug: 500 mg GLPG1837 as oral suspension
* Drug: 500 mg GLPG1837 as oral tablet


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: GLPG1837 as oral suspension fasted<br>Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast | Drug: 500 mg GLPG1837 as oral suspension<br>* A single dose of 500 mg GLPG1837 administered as oral suspension<br>|
| Experimental: GLPG1837 as oral tablet fasted<br>Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast | Drug: 500 mg GLPG1837 as oral tablet<br>* A single dose of 500 mg GLPG1837 administered as oral tablet<br>|
| Experimental: GLPG1837 as oral tablet fed<br>Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast | Drug: 500 mg GLPG1837 as oral tablet<br>* A single dose of 500 mg GLPG1837 administered as oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma | To characterize and compare the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition | Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837) | 
| The concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma | To characterize and compare the concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition | Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837) | 
| The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma | To characterize and compare the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition | Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837) | 
| The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma | To characterize and compare the area under the plasma concentration versus time curve of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition | Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837) | 
| The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma | To characterize and compare the apparent terminal half-life of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition | Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837) | 
| The metabolite over GLPG1837 ratios in plasma | To characterize and compare the metabolite over GLPG1837 ratios in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition | Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of number of adverse events (AEs) reported | Between Screening and 7 to 10 days after the last dose of GLPG1837 | 
| Changes in vital signs as measured by heart rate, blood pressure and oral body temperature | To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in vital signs as measured by heart rate, blood pressure and oral body temperature reported | Between Screening and 7 to 10 days after the last dose of GLPG1837 | 
| Changes in 12-lead ECG measures | To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in 12-ECG measures reported | Between Screening and 7 to 10 days after the last dose of GLPG1837 | 
| Changes in physical exam measures | To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in physical examination reported | Between Screening and 7 to 10 days after the last dose of GLPG1837 | 
| Changes in blood safety lab parameters | To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in blood safety lab parameters reported | Between Screening and 7 to 10 days after the last dose of GLPG1837 | 
| Changes in urine safety lab parameters | To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in urine safety lab parameters reported | Between Screening and 7 to 10 days after the last dose of GLPG1837 |