Oral Bioavailability of GLPG0555 in Different Solid Formulations

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278095
• Other study ID #: GLPG0555-CL-103
• Secondary ID: 2010-022457-42
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2011
• Last updated: March 23, 2011
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0555 solid dispersion
solid dispersion capsules, 50 mg, single dose
• GLPG0555 nanosuspension
Nanosuspension, 50 mg, single dose

Locations

Country	Name	City	State
Belgium	SGS Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of solid formulation		72 hrs	No
Secondary	Safety and tolerability of single doses of GLPG0555		up to 10 days postdose	No