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
  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
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: 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 September 22, 2014