NCT01406002

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

An Open-label, One-sequence Study to Evaluate the Effect of Multiple Doses of Rifampicin on the Pharmacokinetics of YM150 (Darexaban) and Metabolites in Young Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label, 1-sequence study in young healthy male subjects to evaluate the effect of multiple daily doses of rifampicin on the PK of darexaban and metabolites after a single dose of darexaban. In addition, safety and tolerability of darexaban administered alone and in combination with rifampicin is evaluated. Eligible subjects are admitted to the clinical unit in the morning of Day -1. Subjects receive a single dose of darexaban on Day 1. Subjects then receive rifampicin once daily (qd) on Days 4-14.On Day 11, the second single dose of darexaban is given in combination with rifampicin.

Conditions

• Pharmacokinetics of Darexaban and Metabolites
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	darexaban	oral
DRUG	Rifampicin	oral

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2011-07-29
• Last updated: 2013-04-11

Locations

1 site across 1 country: France