Oral Bioavailability of GLPG0555 in Different Solid Formulations

March 23, 2011 updated by: Galapagos NV

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2060
        • SGS Stuivenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male
  • BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioavailability of solid formulation
Time Frame: 72 hrs
72 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of single doses of GLPG0555
Time Frame: up to 10 days postdose
up to 10 days postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Investigators

  • Principal Investigator: Jos Leempoels, MD, SGS Stuivenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GLPG0555-CL-103
  • 2010-022457-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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