NCT01419990

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0634	GLPG0634 300 mg oral capsules, qd, 10 days
DRUG	GLPG0634	GLPG0634 450 mg oral capsules, qd, 10 days
DRUG	Placebo	Placebo oral capsules, qd, 10 days

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-08-19
• Last updated: 2012-08-15

Locations

1 site across 1 country: Belgium