First-in-Human Single and Multiple Dose of GLPG2222

Study Overview
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Brief Summary
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The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2). Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Official Title
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Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG2222 single dose
* Drug: Placebo single dose
* Drug: GLPG2222 multiple doses
* Drug: Placebo multiple doses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males between 18-50 years of age Subjects must have a body mass index between 18-30 kg/m² 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 Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only) Exclusion Criteria: A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug Concurrent participation or participation within 8 weeks 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 Current sexually active (and/or child wish) male; a contraception method must be used

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG2222 single dose<br>Single dose of GLPG2222 oral suspension | Drug: GLPG2222 single dose<br>* single ascending doses, oral suspension<br>|
| Placebo Comparator: Placebo single dose<br>Single dose of placebo oral suspension | Drug: Placebo single dose<br>* single doses, oral suspension, matching placebo<br>|
| Experimental: GLPG2222 multiple doses<br>Multiple doses of GLPG2222 oral suspension | Drug: GLPG2222 multiple doses<br>* multiple ascending doses, daily for 14 days, oral suspension<br>|
| Placebo Comparator: Placebo multiple doses<br>Multiple doses of placebo oral suspension | Drug: Placebo multiple doses<br>* multiple doses, daily for 14 days, oral suspension, matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change versus placebo in number of subjects with adverse events | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events | Between screening and 7-10 days after the last dose | 
| Change versus placebo in number of subjects with abnormal laboratory parameters | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters | Between screening and 7-10 days after the last dose | 
| Change versus placebo in number of subjects with abnormal vital signs | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs | Between screening and 7-10 days after the last dose | 
| Change versus placebo in number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram | Between screening and 7-10 days after the last dose | 
| Change versus placebo in number of subjects with abnormal physical examination | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination | Between screening and 7-10 days after the last dose | 
| Change versus placebo in number of subjects with abnormal pulmonary function | To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry | Between screening and 4 days after the last dose (Part 1 only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG2222 in plasma | To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects | Between Day 1 predose and 48 hours after the (last) dose | 
| The amount of GLPG2222 in urine | To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects | Between Day 1 predose and 24 hours after the (last) dose | 
| Ratio of 6-b-hydroxycortisol/cortisol in urine | To assess the potential of CYP3A4 interaction after repeated oral dosing with GLPG2222 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine | Twelve hours before dosing on Day 1 and Day 14 |