Overview

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

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Aspirin
Clopidogrel
Darexaban
Salicylates
Salicylic Acid
Ticlopidine
Criteria
Inclusion Criteria:

- Body mass index (BMI) between 18.5-30.0 kg/m2

- Male subjects must be non-fertile, i.e. surgically sterilized or must practice an
adequate contraceptive method to prevent pregnancies

Exclusion Criteria:

- Known or suspected hypersensitivity to darexaban or ASA or any components of the
formulation used

- Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of
normal at repeated measures

- Any clinically significant history of any other disease or disorder -
gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological,
dermatological, psychiatric or metabolic as judged by the medical investigator

- Any clinically significant abnormality following the investigator's review of the
pre-study physical examination, ECG and clinical laboratory tests

- Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and
herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the
Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)

- Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the
3 months prior to admission to the Clinical Unit.

- Donation of blood or blood products within 3 months prior to admission to the Clinical
Unit

- Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or
more than 21 units (210 g) of alcohol per week within the 3 months prior to study

- Participation in any clinical study within 3 months or participation in more than 3
clinical studies within 12 months, prior to the expected date of enrolment into the
study, provided that the clinical study did not entail a biological compound with a
long terminal half life