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Oral Bioavailability of Two Solid Formulations of GLPG0259.

This study has been completed.
Information provided by:
Galapagos NV Identifier:
First received: March 22, 2011
Last updated: March 23, 2011
Last verified: March 2011
The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.

Condition Intervention Phase
Healthy Drug: GLPG0259 fumarate Drug: GLPG0259 free base Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized, Open Label, 2-way Crossover Study to Compare the Oral Bioavailability of 2 Solid Dose Formulations of GLPG0259 After Single-dose Intake in Healthy Subjects

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Bioavailability of two solid dosage formulations 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 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single oral dose, single capsule Drug: GLPG0259 free base
single oral dose, GLPG0259, 50 mg solid formulation
Experimental: Single oral dose, two capsules Drug: GLPG0259 fumarate
single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01322451

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

Responsible Party: Senior Vice President Development, Galapagos NV Identifier: NCT01322451     History of Changes
Other Study ID Numbers: GLPG0259-CL-104
2010-022456-23 ( EudraCT Number )
Study First Received: March 22, 2011
Last Updated: March 23, 2011

Keywords provided by Galapagos NV:
Pharmacokinetics processed this record on August 23, 2017