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

NCT ID: NCT03899909

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-29
• Study Completion Date: 2019-06-03

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG3121 SAD

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

Group Type: EXPERIMENTAL

GLPG3121 SAD

Intervention Type: DRUG

GLPG3121 oral suspension, single ascending doses

Placebo SAD

Single doses of placebo

Group Type: PLACEBO_COMPARATOR

Placebo SAD

Intervention Type: DRUG

Placebo oral suspension

GLPG3121 MAD

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

Group Type: EXPERIMENTAL

GLPG3121 MAD

Intervention Type: DRUG

GLPG3121 oral suspension, multiple ascending doses, daily for 13 days

Placebo MAD

Multiple doses of placebo

Group Type: PLACEBO_COMPARATOR

Placebo MAD

Intervention Type: DRUG

Placebo oral suspension, daily for 13 days

Interventions

GLPG3121 SAD

GLPG3121 oral suspension, single ascending doses

Intervention Type: DRUG

Placebo SAD

Placebo oral suspension

Intervention Type: DRUG

GLPG3121 MAD

GLPG3121 oral suspension, multiple ascending doses, daily for 13 days

Intervention Type: DRUG

Placebo MAD

Placebo oral suspension, daily for 13 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magdalena Petkova, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

2018-002174-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3121-CL-101

Identifier Type: -

Identifier Source: org_study_id