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
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: 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 July 29, 2014