Oral Bioavailability of GLPG0555 in Different Solid Formulations

NCT ID: NCT01278095

Last Updated: 2011-03-24

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

2011-01-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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GLPG0555 solid dispersion, fasting

50 mg as solid dispersion capsule, in fasting condition

Group Type EXPERIMENTAL

GLPG0555 solid dispersion

Intervention Type DRUG

solid dispersion capsules, 50 mg, single dose

GLPG0555 solid dispersion, fed

50 mg as solid dispersion capsule, after breakfast

Group Type EXPERIMENTAL

GLPG0555 solid dispersion

Intervention Type DRUG

solid dispersion capsules, 50 mg, single dose

GLPG0555 nanosuspension, fed

50 mg as nanosuspension, given after breakfast

Group Type EXPERIMENTAL

GLPG0555 nanosuspension

Intervention Type DRUG

Nanosuspension, 50 mg, single dose

Interventions

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GLPG0555 solid dispersion

solid dispersion capsules, 50 mg, single dose

Intervention Type DRUG

GLPG0555 nanosuspension

Nanosuspension, 50 mg, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male
* 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

Principal Investigators

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Gerben van 't Klooster, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Jos Leempoels, 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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2010-022457-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG0555-CL-103

Identifier Type: -

Identifier Source: org_study_id

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