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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
26
oral
oral
SGS Aster
Paris, France
Pharmacokinetics of darexaban and its metabolites assessed by plasma concentration
Time frame: Plasma samples are taken until 72 hours after darexaban dosing
Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events
Time frame: 15 days
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