GLPG0259 Solid Formulation Bioavailability and Food Effect

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0259; Drug: GLPG0259 solution

• Registration Number: NCT01024517
• Lead Sponsor: Galapagos NV

Brief Summary

The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage formulation (with and without food)and an oral solution, and to assess its safety and tolerability.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Study Completion: 2010-02
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-26
• Last Update Posted: 2010-04-27

Recruitment & Eligibility

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

Inclusion Criteria

• healthy male, age 18-50 years
• 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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single oral dose, solid, fasted	GLPG0259	-
Single oral dose, solution	GLPG0259 solution	-
Single oral dose, solid, fed.	GLPG0259	-

Primary Outcome Measures

Name	Time	Method
Bioavailability of a solid dosage formulation of GLPG0259 (with/without food) compared to an oral solution of GLPG0259.	up to 96 hours postdose

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of GLPG0259	up to 96 hours postdose

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium