Healthy Subjects Clinical Trial
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
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.
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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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