A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects

Study Overview
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Brief Summary
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This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.

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 GLPG3667 in Adult, Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG3667
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be below the upper limit of normal. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator. This list only contains the key inclusion criteria. Exclusion Criteria: Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator. Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that has resolved at least 3 months prior to first dosing of the IP. This list only contains the key exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG3667 SD<br>Participants will receive a single dose of GLPG3667 | Drug: GLPG3667<br>* GLPG3667 capsules<br>|
| Placebo Comparator: Placebo SD<br>Participants will receive a single dose of matching placebo | Drug: Placebo<br>* Matching placebo capsules<br>|
| Experimental: GLPG3667 MD<br>Participants will receive repeated doses of GLPG3667 for 13 days. | Drug: GLPG3667<br>* GLPG3667 capsules<br>|
| Placebo Comparator: Placebo MD<br>Participants will receive repeated doses of matching placebo for 13 days. | Drug: Placebo<br>* Matching placebo capsules<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, and TEAEs leading to treatment discontinuations | To evaluate the safety and tolerability of single and multiple oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo | From screening through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of GLPG3667 - SD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 4 | 
| Maximum observed plasma concentration (Cmax) of GLPG3667 - MD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 16 | 
| Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 4 | 
| Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 16 | 
| Terminal elimination half-life (t1/2) of GLPG3667 - SD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 4 | 
| Terminal elimination half-life (t1/2) of GLPG3667 - MD | To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects. | Between Day 1 pre-dose and Day 16 |