Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects. Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.

Official Title
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Randomized, Double-blind, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Multiple Oral Doses of GLPG0634 in Japanese and Caucasian Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG0634 50 mg
* Drug: GLPG0634 100 mg
* Drug: GLPG0634 200 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Japanese or Caucasian subjects between 20-65 years of age (included) Subjects must have a body mass index between 18-28 kg/m² (included) Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile Exclusion Criteria: A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug Concurrent participation or participation within 3 months prior to the initial study drug administration in a drug/device or biologic investigational research study A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration Subject expresses current desire to have (more) children Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG0634 in Japanese subjects<br>Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days | Drug: GLPG0634 50 mg<br>* 2 tablets of 25 mg GLPG0634 once daily for 10 days<br>* Other names: 50 mg GLPG0634 as tablets;Drug: GLPG0634 100 mg<br>* 1 tablet of 100 mg GLPG0634 once daily for 10 days<br>* Other names: 100 mg GLPG0634 as tablets;Drug: GLPG0634 200 mg<br>* 2 tablets of 100 mg GLPG0634 once daily for 10 days<br>* Other names: 200 mg GLPG0634 as tablets;|
| Placebo Comparator: Placebo in Japanese healthy subjects<br>Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days | Drug: Placebo<br>* 1 or 2 matching placebo tablets once daily for 10 days<br>* Other names: Placebo as matching tablets;|
| Experimental: GLPG0634 in Caucasian subjects<br>In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days | Drug: GLPG0634 200 mg<br>* 2 tablets of 100 mg GLPG0634 once daily for 10 days<br>* Other names: 200 mg GLPG0634 as tablets;|
| Placebo Comparator: Placebo in Caucasian healthy subjects<br>In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days | Drug: Placebo<br>* 1 or 2 matching placebo tablets once daily for 10 days<br>* Other names: Placebo as matching tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with adverse events | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of adverse events (AEs) | From screening up to 10 days after last dose (Day 20) | 
| The number of subjects with abnormal laboratory parameters | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal laboratory parameters | From screening up to 10 days after last dose (Day 20) | 
| The number of subjects with abnormal vital signs | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal vital signs | From screening up to 10 days after last dose (Day 20) | 
| The number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal electrocardiogram | From screening up to 10 days after last dose (Day 20) | 
| The number of subjects with abnormal physical examination | To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal physical examination | From screening up to 10 days after last dose (Day 20) | 
| The amount of GLPG0634 and metabolite in plasma and urine | To characterize the amount of GLPG0634 and metabolite in plasma and urine over time - pharmacokinetics (PK) - in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested Safety Issue?: No | Between Day 1 before dosing and Day 13 (72 hours after last dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG0634 mechanism-of-action-related biomarkers in blood | To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested | Between Day 1 before dosing and Day 11 (24 hours after last dose) |