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
  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
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 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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014