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GLPG0259 Solid Formulation Bioavailability and Food Effect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024517
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : April 27, 2010
Information provided by:
Galapagos NV

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG0259 solution Drug: GLPG0259 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open Label Study to Compare the Oral Bioavailability of a Solid Dose Formulation of GLPG0259 Relative to an Oral Solution After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Solid Dose Formulation.
Study Start Date : November 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: Single oral dose, solution Drug: GLPG0259 solution
single oral dose, GLPG0259, 50 mg oral solution

Experimental: Single oral dose, solid, fasted Drug: GLPG0259
single oral dose, GLPG0259, 50 mg solid formulation

Experimental: Single oral dose, solid, fed. Drug: GLPG0259
single oral dose, GLPG0259, 50 mg solid formulation

Primary Outcome Measures :
  1. Bioavailability of a solid dosage formulation of GLPG0259 (with/without food) compared to an oral solution of GLPG0259. [ Time Frame: up to 96 hours postdose ]

Secondary Outcome Measures :
  1. Safety and tolerability of GLPG0259 [ Time Frame: up to 96 hours postdose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01024517

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SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
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Study Director: Johan Beetens, PharmD, PhD Galapagos NV
Principal Investigator: Wouter Haazen, MD SGS Stuivenberg
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Responsible Party: Senior Vice President Development, Galapagos NV Identifier: NCT01024517    
Other Study ID Numbers: GLPG0259-CL-103
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010
Keywords provided by Galapagos NV: