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
-
-
-
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
|
solid dispersion capsules, 50 mg, single dose
|
|
Experimental: GLPG0555 solid dispersion, fed
50 mg as solid dispersion capsule, after breakfast
|
solid dispersion capsules, 50 mg, single dose
|
|
Experimental: GLPG0555 nanosuspension, fed
50 mg as nanosuspension, given after breakfast
|
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
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.