Oral Bioavailability of Two Solid Formulations of GLPG0259.

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01322451
First received: March 22, 2011
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ 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 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

  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: 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

No publications provided

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
Study First Received: March 22, 2011
Last Updated: March 23, 2011
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 April 14, 2014