To Evaluate if Multiple Doses of Rifampicin Change the Blood Concentration of YM150 (Darexaban)

Phase 1 Completed 26 enrolled Astellas Pharma Inc

NaSingle-groupOpen-label

Summary

The primary objective of this study is to determine the effect of rifampicin on the way the body handles darexaban and its metabolites (drug degradation products). The secondary objective of the study is to evaluate the safety and tolerability of a single dose of darexaban alone and when administered together with rifampicin.

Timeline

Start: 2010-01
Primary completion: 2010-03
Completion: 2010-03

Publications

Background Groenendaal D, Strabach G, Garcia-Hernandez A, Kadokura T, Heeringa M, Mol R, Eltink C, Onkels H. The pharmacokinetics of darexaban are not affected to a clinically relevant degree by rifampicin, a strong inducer of P-glycoprotein and CYP3A4. Br J Clin Pharmacol. 2013 Feb;75(2):440-9. doi: 10.1111/j.1365-2125.2012.04346.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	darexaban	Small molecule	—	Oral
Background	Rifampin	Small molecule	—	Oral

Indications

No indication recorded.