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

March 19, 2013 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • SGS Aster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm A
ASA, wash-out (w.o.), ASA + darexaban
Drug: darexaban
oral
Other Names:
  • YM150
Drug: Acetyl Salicylic Acid
oral
Other Names:
  • Aspirin
Experimental: Treatment arm B
ASA + darexaban, w.o., ASA
Drug: darexaban
oral
Other Names:
  • YM150
Drug: Acetyl Salicylic Acid
oral
Other Names:
  • Aspirin
Experimental: Treatment arm C
ASA, w.o., darexaban (double dose) + ASA
Drug: Acetyl Salicylic Acid
oral
Other Names:
  • Aspirin
Drug: darexaban (double dose)
oral
Other Names:
  • YM150
Experimental: Treatment arm D
darexaban (double dose) + ASA, w.o., ASA
Drug: Acetyl Salicylic Acid
oral
Other Names:
  • Aspirin
Drug: darexaban (double dose)
oral
Other Names:
  • YM150
Experimental: Treatment arm E
ASA + clopidogrel, w.o., ASA + clopidogrel + darexaban
Drug: darexaban
oral
Other Names:
  • YM150
Drug: Acetyl Salicylic Acid
oral
Other Names:
  • Aspirin
Drug: clopidogrel
oral
Other Names:
  • Plavix
Experimental: Treatment arm F
ASA + clopidogrel + darexaban, w.o., ASA + clopidogrel
Drug: darexaban
oral
Other Names:
  • YM150
Drug: Acetyl Salicylic Acid
oral
Other Names:
  • Aspirin
Drug: clopidogrel
oral
Other Names:
  • Plavix
Experimental: Treatment arm G
ASA + clopidogrel, w.o., darexaban (double dose) + ASA + clopidogrel
Drug: Acetyl Salicylic Acid
oral
Other Names:
  • Aspirin
Drug: darexaban (double dose)
oral
Other Names:
  • YM150
Drug: clopidogrel
oral
Other Names:
  • Plavix
Experimental: Treatment arm H
darexaban (double dose) + ASA + clopidogrel, w.o., ASA + clopidogrel
Drug: Acetyl Salicylic Acid
oral
Other Names:
  • Aspirin
Drug: darexaban (double dose)
oral
Other Names:
  • YM150
Drug: clopidogrel
oral
Other Names:
  • Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of pharmacodynamics of darexaban
Time Frame: Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination
Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of pharmacodynamics of ASA and a combination of ASA and clopidogrel
Time Frame: Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination
Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination
Pharmacokinetics of ASA and the combination of ASA and clopidogrel assessed by plasma concentration
Time Frame: Plasma samples are taken until 24 hours after six days of dosing of ASA, a combination of ASA and clopidogrel, or the combination with darexaban
Plasma samples are taken until 24 hours after six days of dosing of ASA, a combination of ASA and clopidogrel, or the combination with darexaban
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Time Frame: 6 days for each of the 2 treatment periods
6 days for each of the 2 treatment periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Principal Investigator: Principal Investigator, SGS Aster, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimate)

August 4, 2011

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-035
  • 2007-007036-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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