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Oral Bioavailability of GLPG0555 in Different Solid Formulations

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01278095
First received: January 14, 2011
Last updated: March 23, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.


Condition Intervention Phase
Healthy
 Drug: GLPG0555 solid dispersion
Drug: GLPG0555 nanosuspension
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized, Open Label, 3-way Crossover Study to Compare the Oral Bioavailability of GLPG0555 After Single-dose Intake in Healthy Subjects as a Solid Dispersion Formulation, With and Without Food, Relative to a Nanosuspension Formulation

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Bioavailability of solid formulation [ Time Frame: 72 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of single doses of GLPG0555 [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLPG0555 solid dispersion, fasting
50 mg as solid dispersion capsule, in fasting condition
 Drug: GLPG0555 solid dispersion
solid dispersion capsules, 50 mg, single dose
Experimental: GLPG0555 solid dispersion, fed
50 mg as solid dispersion capsule, after breakfast
 Drug: GLPG0555 solid dispersion
solid dispersion capsules, 50 mg, single dose
Experimental: GLPG0555 nanosuspension, fed
50 mg as nanosuspension, given after breakfast
 Drug: GLPG0555 nanosuspension
Nanosuspension, 50 mg, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male
  • 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: NCT01278095

Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium, 2060
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Gerben van 't Klooster, PhD Galapagos NV
Principal Investigator: Jos Leempoels, MD SGS Stuivenberg
  More Information

No publications provided

Responsible Party: Senior Vice President Development, Galapagos
ClinicalTrials.gov Identifier: NCT01278095     History of Changes
Other Study ID Numbers: GLPG0555-CL-103, 2010-022457-42
Study First Received: January 14, 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 May 23, 2013