First-in-Human Single and Multiple Dose of GLPG1837

Lakefront Biotherapeutics NV64 enrolled

Overview

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized. The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated. The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females of non-child bearing potential between 18-50 years of age (included) * Subjects must have a body mass index between 18-30 kg/m² (included) * 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 findings 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 or participation within 15 weeks prior to initial study drug administration in an investigational research study with antibody administration * 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 should be used * Pregnant or lactating women or women of childbearing potential

Outcomes

Primary Outcomes

Number of subjects with adverse events

To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events