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GLPG0259 Solid Formulation Bioavailability and Food Effect

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ClinicalTrials.gov Identifier: NCT01024517
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:
Galapagos NV

Study Description
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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

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01024517


Locations
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Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Johan Beetens, PharmD, PhD Galapagos NV
Principal Investigator: Wouter Haazen, MD SGS Stuivenberg
More Information
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Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov 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:
Safety
Tolerability
Pharmacokinetics