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

August 1, 2011
August 25, 2011
December 2007
March 2008   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01424332 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
To Evaluate Whether Acetyl Salicylic Acid (Aspirin) and Darexaban (YM150) Interact in Their Effects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Pharmacodynamic and Pharmacokinetic Interaction
  • Healthy Subjects
  • Drug: Darexaban
    oral
    Other Name: YM150
  • Drug: Acetyl Salicylic Acid (ASA)
    oral
    Other Name: Aspirin
  • Experimental: Treatment arm 1
    darexaban, wash-out, ASA, wash-out, darexaban plus ASA
    Interventions:
    • Drug: Darexaban
    • Drug: Acetyl Salicylic Acid (ASA)
  • Experimental: Treatment arm 2
    darexaban, wash-out, darexaban plus ASA, wash-out, ASA
    Interventions:
    • Drug: Darexaban
    • Drug: Acetyl Salicylic Acid (ASA)
  • Experimental: Treatment arm 3
    ASA, wash-out, darexaban, wash-out, darexaban plus ASA
    Interventions:
    • Drug: Darexaban
    • Drug: Acetyl Salicylic Acid (ASA)
  • Experimental: Treatment arm 4
    ASA, wash-out, darexaban plus ASA, wash-out, darexaban
    Interventions:
    • Drug: Darexaban
    • Drug: Acetyl Salicylic Acid (ASA)
  • Experimental: Treatment arm 5
    darexaban plus ASA, wash-out, darexaban, wash-out, ASA
    Interventions:
    • Drug: Darexaban
    • Drug: Acetyl Salicylic Acid (ASA)
  • Experimental: Treatment arm 6
    darexaban plus ASA, wash-out, ASA, wash-out, darexaban
    Interventions:
    • Drug: Darexaban
    • Drug: Acetyl Salicylic Acid (ASA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01424332
150-CL-034, 2007-002194-31
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Principal Investigator: Principal Investigator SGS Aster, Paris, France
Astellas Pharma Inc
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP