To Evaluate if Multiple Doses of Rifampicin Change the Blood Concentration of YM150 (Darexaban)
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.
Pharmacokinetics of Darexaban and Metabolites
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||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|
- Pharmacokinetics of darexaban and its metabolites assessed by plasma concentration [ Time Frame: Plasma samples are taken until 72 hours after darexaban dosing ] [ Designated as safety issue: No ]
- Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment arm 1
darexaban, wash-out, rifampicin + darexaban
Other Name: YM150Drug: Rifampicin
Other Name: Rifadin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406002
|Paris, France, 75015|
|Study Chair:||Clinical Study Manager||Astellas Pharma Europe B.V.|
|Principal Investigator:||Prinicpal Investigator||SGS Aster, Paris, France|