Oral Bioavailability of Two Solid Formulations of GLPG0259.

NCT ID: NCT01322451

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single oral dose, single capsule

Group Type EXPERIMENTAL

GLPG0259 free base

Intervention Type DRUG

single oral dose, GLPG0259, 50 mg solid formulation

Single oral dose, two capsules

Group Type EXPERIMENTAL

GLPG0259 fumarate

Intervention Type DRUG

single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GLPG0259 fumarate

single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate

Intervention Type DRUG

GLPG0259 free base

single oral dose, GLPG0259, 50 mg solid formulation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Galapagos NV

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Galapagos NV

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johan Beetens, PharmD, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Lien Gheyle, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Stuivenberg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SGS Stuivenberg

Antwerp, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-022456-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG0259-CL-104

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AZD9056 Relative Bioavailability Study
NCT00908934 COMPLETED PHASE1