First-in-Human Single Ascending and Multiple Dose of GLPG0259

Phase 1

Completed

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

• Registration Number: NCT00905138
• Lead Sponsor: Galapagos NV

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	single dose placebo
3	GLPG0259	multiple dose, 5 days, oral solution
4	placebo	multiple dose, 5 days, oral solution
1	GLPG0259	single ascending doses

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single and multiple dosing	up to 10 days postdose

Secondary Outcome Measures

Name	Time	Method
Exploratory evaluation of TNF-alpha and IL6 in whole blood	up to 12 hours postdose
Pharmacokinetics of single and repeated doses	up to 10 days postdose

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium