Oral Bioavailability of GLPG0555 in Different Solid Formulations

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0555 solid dispersion; Drug: GLPG0555 nanosuspension

• Registration Number: NCT01278095
• Lead Sponsor: Galapagos NV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Primary Completion: 2011-02
• Status Verified: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-23
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG0555 solid dispersion, fasting	GLPG0555 solid dispersion	50 mg as solid dispersion capsule, in fasting condition
GLPG0555 solid dispersion, fed	GLPG0555 solid dispersion	50 mg as solid dispersion capsule, after breakfast
GLPG0555 nanosuspension, fed	GLPG0555 nanosuspension	50 mg as nanosuspension, given after breakfast

Primary Outcome Measures

Name	Time	Method
Bioavailability of solid formulation	72 hrs

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of single doses of GLPG0555	up to 10 days postdose

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium