A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Healthy Japanese and Caucasian Male Subjects

Study Overview
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Brief Summary
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The purpose of this research study is to assess the safety and tolerability of GLPG1205 in single and multiple oral doses in healthy male Caucasian and Japanese subjects. This study will also assess the pharmacokinetics (PK) across different doses of GLPG1205. PK will look at how the study drug is absorbed, broken down, and eliminated by your body.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of GLPG1205 for 14 Days in Healthy Japanese and Caucasian Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG1205
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian and Japanese male between 20-55 years of age (extremes included), on the date of signing the informed consent form (ICF). Japanese subjects must be first generation Japanese of full Japanese parentage, and must have not lived outside Japan for more than 5 years. First generation subjects will have been born in Japan of 2 parents and 4 grandparents also born in Japan of full Japanese descent. A body mass index (BMI) between 18-26 kg/m2, extremes included, with a minimum body weight of 45 kg. Able and willing to comply with the protocol requirements and signing the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations. Exclusion Criteria: History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to the investigational product (IP) or its excipients as determined by the investigator. Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG1205 dose A<br>Participants will receive a single dose with dose A of GLPG1205 on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2. | Drug: GLPG1205<br>* GLPG1205 film-coated tablets<br>|
| Placebo Comparator: Placebo dose A<br>Participants will receive a single dose placebo on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2. | Drug: Placebo<br>* placebo film-coated tablets<br>|
| Experimental: GLPG1205 dose B<br>Participants will receive 14 days q.d. dosing with dose B of GLPG1205 on Days 1 to 14. | Drug: GLPG1205<br>* GLPG1205 film-coated tablets<br>|
| Placebo Comparator: Placebo dose B<br>Participants will receive 14 days q.d. dosing placebo on Days 1 to 14. | Drug: Placebo<br>* placebo film-coated tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation | To evaluate the safety and tolerability of single and multiple oral doses of GLPG1205 in healthy male Japanese and Caucasian subjects | From screening through study completion, an average of 3 months | 
| Maximum observed plasma concentration (Cmax) of GLPG1205 | To assess the PK of single and multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects | Between Day 1 pre-dose and Day 18 and at follow-up Day 32 | 
| Area under the plasma concentration-time curve from time zero till 24 hours postdose (AUC 0-24h) of GLPG1205 | To assess the PK of single oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects | Between Day 1 pre-dose and Day 18 and at follow-up Day 32 | 
| Area under the plasma concentration-time curve over the dosing interval (AUC T) of GLPG1205 | To assess the PK of multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects | Between Day 1 pre-dose and Day 18 and at follow-up Day 32 |