First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0187; Drug: Placebo

• Registration Number: NCT00928343
• Lead Sponsor: Galapagos NV

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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
GLPG0187	GLPG0187	Single dose
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single subcutaneous and oral dosing	up to day 10 postdose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of single subcutaneous and oral doses	up to 10 days postdose
Exploratory evaluation of S-CTX	up to 24 hrs postdose

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium