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Oral Bioavailability of Two Solid Formulations of GLPG0634

NCT ID: NCT01915667

Last Updated: 2013-09-17

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

2013-07-31

Study Completion Date

2013-09-30

Brief Summary

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The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.

Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GLPG0634 capsule fasted

Single dose of GLPG0634 as capsules in fasted condition

Group Type EXPERIMENTAL

200 mg GLPG0634 as capsules, fasted

Intervention Type DRUG

single oral dose of 200 mg GLPG0634 given as capsules in fasted condition

GLPG0634 tablet fasted

Single dose of GLPG0634 as tablets in fasted condition

Group Type EXPERIMENTAL

200 mg GLPG0634 as tablets, fasted

Intervention Type DRUG

single oral dose of 200 mg GLPG0634 given as tablets in fasted condition

GLPG0634 tablet fed

Single dose of GLPG0634 as tablets in fed condition

Group Type ACTIVE_COMPARATOR

200 mg GLPG0634 as tablets, fed

Intervention Type DRUG

single oral dose of 200 mg GLPG0634 given as tablets in fed condition

Interventions

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200 mg GLPG0634 as capsules, fasted

single oral dose of 200 mg GLPG0634 given as capsules in fasted condition

Intervention Type DRUG

200 mg GLPG0634 as tablets, fasted

single oral dose of 200 mg GLPG0634 given as tablets in fasted condition

Intervention Type DRUG

200 mg GLPG0634 as tablets, fed

single oral dose of 200 mg GLPG0634 given as tablets in fed condition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male, age 40-60 years
* BMI between 18-30 kg/m2

Exclusion Criteria

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 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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Pille Harrison, 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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GLPG0634-CL-107

Identifier Type: -

Identifier Source: org_study_id