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First-in-Human Single and Multiple Dose of GLPG2222

NCT ID: NCT02662452

Last Updated: 2016-07-29

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-05-31

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 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.

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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GLPG2222 single dose

Single dose of GLPG2222 oral suspension

Group Type EXPERIMENTAL

GLPG2222 single dose

Intervention Type DRUG

single ascending doses, oral suspension

Placebo single dose

Single dose of placebo oral suspension

Group Type PLACEBO_COMPARATOR

Placebo single dose

Intervention Type DRUG

single doses, oral suspension, matching placebo

GLPG2222 multiple doses

Multiple doses of GLPG2222 oral suspension

Group Type EXPERIMENTAL

GLPG2222 multiple doses

Intervention Type DRUG

multiple ascending doses, daily for 14 days, oral suspension

Placebo multiple doses

Multiple doses of placebo oral 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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GLPG2222 single dose

single ascending doses, oral suspension

Intervention Type DRUG

Placebo single dose

single doses, oral suspension, matching placebo

Intervention Type DRUG

GLPG2222 multiple doses

multiple ascending 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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Galapagos NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsteen Donaldson, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

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SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2015-004466-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG2222-CL-101

Identifier Type: -

Identifier Source: org_study_id