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GLPG0259 Solid Formulation Bioavailability and Food Effect

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01024517
First received: December 1, 2009
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of GLPG0259 [ Time Frame: up to 96 hours postdose ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01024517     History of Changes
Other Study ID Numbers: GLPG0259-CL-103
Study First Received: December 1, 2009
Last Updated: April 26, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics

ClinicalTrials.gov processed this record on May 19, 2013