drugset / Trial / NCT02162355

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

NCT02162355

Phase 1 Completed 36 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2014-06
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Filgotinib Small molecule 50 mg Oral
Subject Filgotinib Small molecule 100 mg Oral
Subject Filgotinib Small molecule 200 mg Oral

Indications

No indication recorded.