Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects

Study Overview
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Brief Summary
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This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg [14C]-radiolabeled GLPG0634. The study aims to establish the elimination pathways of GLPG0634 and their relative significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta. Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634 will be evaluated. This study will also provide safety and tolerability information for GLPG0634.

Official Title
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Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects Following a Single Oral Administration of [14C] GLPG0634

Conditions
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Healthy

Intervention / Treatment
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* Drug: 100 mg dose of [14C] GLPG0634


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male, between 40 and 65 years of age, inclusive within BMI range 18 to 30 kg/m2, inclusive 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: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C] GLPG0634<br>Subjects will be dosed with a single oral 100 mg dose of [14C] GLPG0634 on one occasion | Drug: 100 mg dose of [14C] GLPG0634<br>* Subjects will be dosed with a single oral 100 mg dose of [14C] GLPG0634 on one occasion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of total radioactivity in urine and faeces over time after a single dose of radiolabeled GLPG0634 | To evaluate the mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined to determine the elimination pathways and their relative significance after a single dose of radiolabeled GLPG0634 | Day -1 (pre-dosing) up to Day 10 post dosing | 
| The amount of GLPG0634 and its main metabolites in urine and faeces over time after a single dose of radiolabeled GLPG0634 | To evaluate the recovery of GLPG0634 and its main metabolites in urine and faeces after a single dose of radiolabeled GLPG0634 to determine the elimination pathways and their relative significance (excretion and renal clearance) | Day -1 (pre-dosing) up to Day 10 post dosing | 
| Identification of metabolites over time in plasma, urine and faeces after a single dose of radiolabeled GLPG0634 | Metabolite profiling and identification in plasma, urine and faeces over time after a single dose of radiolabeled GLPG0634 | Day -1 (pre-dosing) up to Day 10 post dosing | 
| The amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634 | To characterize the amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634 | Day 1 (pre-dosing) up to Day 8 post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of the number of adverse events reported | Screening up to Day 10 post dosing | 
| Changes in vital signs as measured by heart rate, blood pressure and oral temperature | To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in vital signs as measured by heart rate, blood pressure and oral temperature reported | Screening up to Day 10 post dosing | 
| Changes in 12-lead ECG measures | To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in 12-ECG measures reported | Screening up to Day 10 post dosing | 
| Changes in physical exam measures | To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in physical exam measures reported | Screening up to Day 10 post dosing | 
| Changes in blood safety lab parameters | To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in blood safety lab parameters reported | Screening up to Day 10 post dosing | 
| Changes in urine safety lab parameters | To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in urine safety lab parameters reported | Screening up to Day 10 post dosing |