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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG3121 MAD; Drug: Placebo MAD; Drug: Placebo SAD; Drug: GLPG3121 SAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT03899909

2018-002174-40 (EudraCT Number)

GLPG3121-CL-101

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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31 participants in 4 patient groups, including a placebo group

GLPG3121 SAD

Experimental group

Description:

Single doses of GLPG3121 at up to 6 dose levels in ascending order

Treatment:

Drug: GLPG3121 SAD

Placebo SAD

Placebo Comparator group

Description:

Single doses of placebo

Treatment:

Drug: Placebo SAD

GLPG3121 MAD

Experimental group

Description:

Multiple doses of GLPG3121 at up to 4 dose levels in ascending order

Treatment:

Drug: GLPG3121 MAD

Placebo MAD

Placebo Comparator group

Description:

Multiple doses of placebo

Treatment:

Drug: Placebo MAD