NCT01409616

To Evaluate Whether Acetyl Salicylic Acid (Aspirin), the Combination of Aspirin and Clopidogrel and Darexaban (YM150) Interact in Their Effects

A Randomized, Open-label, Two-period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Effect of Darexaban (YM150) on Acetyl Salicylic Acid (ASA) and of Darexaban on the Combination of ASA and Clopidogrel at Steady State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate whether ASA, the combination of ASA and clopidogrel, and darexaban, which have different effects on blood coagulation, influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.

Conditions

• Pharmacodynamic Interaction
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	darexaban	oral
DRUG	darexaban (double dose)	oral
DRUG	Acetyl Salicylic Acid	oral
DRUG	clopidogrel	oral

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2011-08-04
• Last updated: 2013-03-21

Locations

1 site across 1 country: France