First-in-Human Single Ascending and Multiple Dose of GLPG0555

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: placebo; Drug: GLPG0555

• Registration Number: NCT01023321
• 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 GLPG0555 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 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: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-11
• Last Update Posted: 2010-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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
1	GLPG0555	single ascending doses
3	GLPG0555	multiple dose, 7 or 14 days, oral solution
4	placebo	multiple dose, 7 or 14 days, oral solution

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
Pharmacokinetics of single and repeated doses, including effect of food.	up to 10 days postdose
To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration	up to 72 hours postdose

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium