To Evaluate Whether Acetyl Salicylic Acid (Aspirin) and Darexaban (YM150) Interact in Their Effects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01424332
First received: August 1, 2011
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

The primary objective of this study is to evaluate whether ASA 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.


Condition Intervention Phase
Pharmacodynamic and Pharmacokinetic Interaction
Healthy Subjects
Drug: Darexaban
Drug: Acetyl Salicylic Acid (ASA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomized, Open Label, Three-way Crossover Study to Evaluate the Pharmacodynamic Interactions Between Darexaban (YM150)/Darexaban Glucuronide (YM-222714) and Acetyl Salicylic Acid (ASA) in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Composite assessment of pharmacodynamics of darexaban and darexaban glucuronide [ Time Frame: Baseline and after six days of dosing of darexaban, ASA, or a combination of the two ] [ Designated as safety issue: No ]
    Assessment includes skin bleeding time, factor Xa, platelet aggregation, thromboxane B2 synthesis, PT & aPTT


Secondary Outcome Measures:
  • Pharmacokinetics of darexaban and darexaban glucuronide assessed by plasma concentration [ Time Frame: Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with ASA ] [ Designated as safety issue: No ]
  • 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 3 treatment periods ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of ASA assessed by plasma concentration [ Time Frame: Plasma samples are taken until 2 hours after six days of dosing of ASA, or the combination with darexaban ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm 1
darexaban, wash-out, ASA, wash-out, darexaban plus ASA
Drug: Darexaban
oral
Other Name: YM150
Drug: Acetyl Salicylic Acid (ASA)
oral
Other Name: Aspirin
Experimental: Treatment arm 2
darexaban, wash-out, darexaban plus ASA, wash-out, ASA
Drug: Darexaban
oral
Other Name: YM150
Drug: Acetyl Salicylic Acid (ASA)
oral
Other Name: Aspirin
Experimental: Treatment arm 3
ASA, wash-out, darexaban, wash-out, darexaban plus ASA
Drug: Darexaban
oral
Other Name: YM150
Drug: Acetyl Salicylic Acid (ASA)
oral
Other Name: Aspirin
Experimental: Treatment arm 4
ASA, wash-out, darexaban plus ASA, wash-out, darexaban
Drug: Darexaban
oral
Other Name: YM150
Drug: Acetyl Salicylic Acid (ASA)
oral
Other Name: Aspirin
Experimental: Treatment arm 5
darexaban plus ASA, wash-out, darexaban, wash-out, ASA
Drug: Darexaban
oral
Other Name: YM150
Drug: Acetyl Salicylic Acid (ASA)
oral
Other Name: Aspirin
Experimental: Treatment arm 6
darexaban plus ASA, wash-out, ASA, wash-out, darexaban
Drug: Darexaban
oral
Other Name: YM150
Drug: Acetyl Salicylic Acid (ASA)
oral
Other Name: Aspirin

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424332

Locations
France
SGS Aster
Paris, France, 75015
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Principal Investigator: Principal Investigator SGS Aster, Paris, France
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01424332     History of Changes
Other Study ID Numbers: 150-CL-034, 2007-002194-31
Study First Received: August 1, 2011
Last Updated: August 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Astellas Pharma Inc:
Pharmacodynamics
pharmacokinetics
darexaban
Acetyl Salicylic Acid
darexaban glucuronide
YM150
YM-222714
Phase 1

Additional relevant MeSH terms:
Aspirin
Salicylates
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014