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Oral Bioavailability of Two Solid Formulations of GLPG0259.

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ClinicalTrials.gov Identifier: NCT01322451
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : March 24, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG0259 fumarate Drug: GLPG0259 free base Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : November 2010
Primary Completion Date : December 2010
Study Completion Date : January 2011
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Bioavailability of two solid dosage formulations 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

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): NCT01322451


Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
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
ClinicalTrials.gov Identifier: NCT01322451     History of Changes
Other Study ID Numbers: GLPG0259-CL-104
2010-022456-23 ( EudraCT Number )
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics