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

NCT ID: NCT01409616

Last Updated: 2013-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment arm A

ASA, wash-out (w.o.), ASA + darexaban

Group Type: EXPERIMENTAL

darexaban

Intervention Type: DRUG

oral

Acetyl Salicylic Acid

Intervention Type: DRUG

oral

Treatment arm B

ASA + darexaban, w.o., ASA

Group Type: EXPERIMENTAL

darexaban

Intervention Type: DRUG

oral

Acetyl Salicylic Acid

Intervention Type: DRUG

oral

Treatment arm C

ASA, w.o., darexaban (double dose) + ASA

Group Type: EXPERIMENTAL

darexaban (double dose)

Intervention Type: DRUG

oral

Acetyl Salicylic Acid

Intervention Type: DRUG

oral

Treatment arm D

darexaban (double dose) + ASA, w.o., ASA

Group Type: EXPERIMENTAL

darexaban (double dose)

Intervention Type: DRUG

oral

Acetyl Salicylic Acid

Intervention Type: DRUG

oral

Treatment arm E

ASA + clopidogrel, w.o., ASA + clopidogrel + darexaban

Group Type: EXPERIMENTAL

darexaban

Intervention Type: DRUG

oral

Acetyl Salicylic Acid

Intervention Type: DRUG

oral

clopidogrel

Intervention Type: DRUG

oral

Treatment arm F

ASA + clopidogrel + darexaban, w.o., ASA + clopidogrel

Group Type: EXPERIMENTAL

darexaban

Intervention Type: DRUG

oral

Acetyl Salicylic Acid

Intervention Type: DRUG

oral

clopidogrel

Intervention Type: DRUG

oral

Treatment arm G

ASA + clopidogrel, w.o., darexaban (double dose) + ASA + clopidogrel

Group Type: EXPERIMENTAL

darexaban (double dose)

Intervention Type: DRUG

oral

Acetyl Salicylic Acid

Intervention Type: DRUG

oral

clopidogrel

Intervention Type: DRUG

oral

Treatment arm H

darexaban (double dose) + ASA + clopidogrel, w.o., ASA + clopidogrel

Group Type: EXPERIMENTAL

darexaban (double dose)

Intervention Type: DRUG

oral

Acetyl Salicylic Acid

Intervention Type: DRUG

oral

clopidogrel

Intervention Type: DRUG

oral

Interventions

darexaban

oral

Intervention Type: DRUG

darexaban (double dose)

oral

Intervention Type: DRUG

Acetyl Salicylic Acid

oral

Intervention Type: DRUG

clopidogrel

oral

Intervention Type: DRUG

Other Intervention Names

YM150; YM150; Aspirin; Plavix

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

SGS Aster, Paris, France

Locations

SGS Aster

Paris, , France

Countries

France

Other Identifiers

2007-007036-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

150-CL-035

Identifier Type: -

Identifier Source: org_study_id