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GLPG0259 Solid Formulation Bioavailability and Food Effect

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01024517
First Posted: December 2, 2009
Last Update Posted: April 27, 2010
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.
Information provided by:
Galapagos NV
  Purpose
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 Intervention Phase
Healthy Drug: GLPG0259 solution Drug: GLPG0259 Phase 1

Study Type: Interventional
Study Design: 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.

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • 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:
  • Safety and tolerability of GLPG0259 [ Time Frame: up to 96 hours postdose ]

Enrollment: 12
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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
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
Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Johan Beetens, PharmD, PhD Galapagos NV
Principal Investigator: Wouter Haazen, MD SGS Stuivenberg
  More Information

Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01024517     History of Changes
Other Study ID Numbers: GLPG0259-CL-103
First Submitted: December 1, 2009
First Posted: December 2, 2009
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics

Additional relevant MeSH terms:
Pharmaceutical Solutions