First-in-Human Single and Multiple Dose of GLPG2222

Galapagos NV40 enrolled

Overview

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2). Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

GLPG2222 single doseDRUG

single ascending doses, oral suspension

Placebo single doseDRUG

single doses, oral suspension, matching placebo

GLPG2222 multiple dosesDRUG

multiple ascending doses, daily for 14 days, oral suspension

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males between 18-50 years of age * Subjects must have a body mass index between 18-30 kg/m² * Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile * Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only) Exclusion Criteria: * A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug * Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study * A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration * Current sexually active (and/or child wish) male; a contraception method must be used

Locations (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Outcomes

Primary Outcomes

Change versus placebo in number of subjects with adverse events

To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events