A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects

Study Overview
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Brief Summary
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This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.

Official Title
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A First-in-human, Randomized, Double-blind, Placebo-controlled, Single Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3121 for 13 Days in Adult, Healthy, Male Subjects.

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG3121 SAD
* Drug: Placebo SAD
* Drug: GLPG3121 MAD
* Drug: Placebo MAD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to comply with the protocol requirements and signing the Informed Consent Form (ICF) as approved by the Independent Ethical Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations. Male between 18 to 55 years of age (extremes included), on the date of signing the ICF. A Body Mass Index (BMI) between 18.0 to 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, (triplicate) 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x the upper limit of normal range (ULN). 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 nonclinically significant in the opinion of the investigator. Exclusion Criteria: Known hypersensitivity to investigational medicinal product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator. Known contraindication or hypersensitivity to interferon-α (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part). Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP. Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min a 24-hours urine collection to assess creatinine clearance can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. History of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.

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: GLPG3121 SAD<br>Single doses of GLPG3121 at up to 6 dose levels in ascending order | Drug: GLPG3121 SAD<br>* GLPG3121 oral suspension, single ascending doses<br>|
| Placebo Comparator: Placebo SAD<br>Single doses of placebo | Drug: Placebo SAD<br>* Placebo oral suspension<br>|
| Experimental: GLPG3121 MAD<br>Multiple doses of GLPG3121 at up to 4 dose levels in ascending order | Drug: GLPG3121 MAD<br>* GLPG3121 oral suspension, multiple ascending doses, daily for 13 days<br>|
| Placebo Comparator: Placebo MAD<br>Multiple doses of placebo | Drug: Placebo MAD<br>* Placebo oral suspension, daily for 13 days<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 ascending oral doses of GLPG3121, in adult, healthy, male subjects compared with placebo. | From screening through study completion, an average of 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of GLPG3121 (μg/mL) | To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects | Between Day 1 pre-dose and Day 16 | 
| Area under curve (AUC) of GLPG3121 (μg.h/mL) | To evaluate the PK of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects | Between Day 1 pre-dose and Day 16 | 
| Terminal elimination half-life (t1/2) of GLPG3121 (h) | To evaluate the PK of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects | Between Day 1 pre-dose and Day 16 |