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Oral Bioavailability of Two Solid Formulations of GLPG0259.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01322451
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : March 24, 2011
Sponsor:
Information provided by:
Galapagos NV

Tracking Information
First Submitted Date  ICMJE March 22, 2011
First Posted Date  ICMJE March 24, 2011
Last Update Posted Date March 24, 2011
Study Start Date  ICMJE November 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
Bioavailability of two solid dosage formulations of GLPG0259 [ Time Frame: up to 96 hours postdose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
Safety and tolerability of GLPG0259 [ Time Frame: up to 96 hours postdose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Bioavailability of Two Solid Formulations of GLPG0259.
Official Title  ICMJE 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
Brief Summary The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: GLPG0259 fumarate
    single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate
  • Drug: GLPG0259 free base
    single oral dose, GLPG0259, 50 mg solid formulation
Study Arms  ICMJE
  • Experimental: Single oral dose, single capsule
    Intervention: Drug: GLPG0259 free base
  • Experimental: Single oral dose, two capsules
    Intervention: Drug: GLPG0259 fumarate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2011)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01322451
Other Study ID Numbers  ICMJE GLPG0259-CL-104
2010-022456-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Senior Vice President Development, Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johan Beetens, PharmD, PhD Galapagos NV
Principal Investigator: Lien Gheyle, MD SGS Stuivenberg
PRS Account Galapagos NV
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP