NCT02162355

Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects

Randomized, Double-blind, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Multiple Oral Doses of GLPG0634 in Japanese and Caucasian Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects. Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0634 50 mg	2 tablets of 25 mg GLPG0634 once daily for 10 days
DRUG	GLPG0634 100 mg	1 tablet of 100 mg GLPG0634 once daily for 10 days
DRUG	GLPG0634 200 mg	2 tablets of 100 mg GLPG0634 once daily for 10 days
DRUG	Placebo	1 or 2 matching placebo tablets once daily for 10 days

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-06-12
• Last updated: 2014-09-16

Locations

1 site across 1 country: United Kingdom