Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0634; Drug: Placebo

• Registration Number: NCT01419990
• Lead Sponsor: Galapagos NV

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.

During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-19
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-14
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Healthy male, age 40-60 years
• BMI between 18-30 kg/m2

Exclusion Criteria

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG0634 capsules	GLPG0634	-
Placebo capsules	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	From screening up to 10 days after the last dose	To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) and pharmacodynamics (PD)	From first dose up to 10 days after the last dose	To determine the plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters as a measure of PD

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium