First-in-Human Single and Multiple Dose of GLPG1837

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GLPG1837 single dose

Single oral dose of GLPG1837 suspension - ascending doses

Group Type EXPERIMENTAL

GLPG1837 single ascending doses

Intervention Type DRUG

Single dose, oral suspension

Placebo single dose

Single oral dose of placebo suspension

Group Type PLACEBO_COMPARATOR

Placebo single dose

Intervention Type DRUG

Single dose, oral suspension matching placebo

GLPG1837 muliple doses

Multiple oral doses of GLPG1837 suspension - ascending doses

Group Type EXPERIMENTAL

GLPG1837 multiple ascending doses

Intervention Type DRUG

Multiple doses, daily for 14 days, oral suspension

Placebo multiple doses

Multiple oral doses of placebo suspension

Group Type PLACEBO_COMPARATOR

Placebo multiple doses

Intervention Type DRUG

Multiple doses, daily for 14 days, oral suspension, matching placebo

Interventions

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GLPG1837 single ascending doses

Single dose, oral suspension

Intervention Type DRUG

Placebo single dose

Single dose, oral suspension matching placebo

Intervention Type DRUG

GLPG1837 multiple ascending doses

Multiple doses, daily for 14 days, oral suspension

Intervention Type DRUG

Placebo multiple doses

Multiple doses, daily for 14 days, oral suspension, matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes