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GLPG0259 Solid Formulation Bioavailability and Food Effect

NCT ID: NCT01024517

Last Updated: 2010-04-27

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-02-28

Brief Summary

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The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage formulation (with and without food)and an oral solution, and to assess its safety and tolerability.

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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

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Single oral dose, solution

Group Type EXPERIMENTAL

GLPG0259 solution

Intervention Type DRUG

single oral dose, GLPG0259, 50 mg oral solution

Single oral dose, solid, fasted

Group Type EXPERIMENTAL

GLPG0259

Intervention Type DRUG

single oral dose, GLPG0259, 50 mg solid formulation

Single oral dose, solid, fed.

Group Type EXPERIMENTAL

GLPG0259

Intervention Type DRUG

single oral dose, GLPG0259, 50 mg solid formulation

Interventions

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GLPG0259 solution

single oral dose, GLPG0259, 50 mg oral solution

Intervention Type DRUG

GLPG0259

single oral dose, GLPG0259, 50 mg solid formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
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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Galapagos NV

Principal Investigators

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Johan Beetens, PharmD, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Wouter Haazen, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Stuivenberg

Locations

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SGS Stuivenberg

Antwerp, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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GLPG0259-CL-103

Identifier Type: -

Identifier Source: org_study_id

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