Double-blind Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 in Healthy Subjects

Galapagos NV1 site in 1 country16 target enrollmentAugust 2011

ConditionsHealthy

InterventionsGLPG0634 Placebo

DrugsGLPG0634 Placebo

Overview

Phase: Phase 1
Intervention: GLPG0634
Conditions: Healthy
Sponsor: Galapagos NV
Enrollment: 16
Locations: 1
Primary Endpoint: Safety and tolerability
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

October 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Galapagos NV

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

GLPG0634 capsules

Intervention: GLPG0634

Placebo capsules

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerability

Time Frame: 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