Oral Bioavailability of Two Solid Formulations of GLPG0259.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0259 free base; Drug: GLPG0259 fumarate

• Registration Number: NCT01322451
• Lead Sponsor: Galapagos NV

Brief Summary

The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2011-03
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-23
• Last Update Submitted: 2011-03-23
• Study First Posted: 2011-03-24
• Last Update Posted: 2011-03-24

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, single capsule	GLPG0259 free base	-
Single oral dose, two capsules	GLPG0259 fumarate	-

Primary Outcome Measures

Name	Time	Method
Bioavailability of two solid dosage formulations 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