First-in-Human Single Ascending and Multiple Dose of GLPG0634

Phase 1 Completed 48 enrolled Lakefront Biotherapeutics NV

RandomizedParallel-groupQuadruple-blind

Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food). Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Timeline

Start: 2010-08
Primary completion: 2011-03
Completion: 2011-03

Publications

Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filgotinib	Small molecule	1 mg	Oral
Subject	Filgotinib	Small molecule	10 mg	Oral
Subject	Filgotinib	Small molecule	200 mg	Oral

Indications

No indication recorded.