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CompletedNCT01424332Updated Aug 29, 2011

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

A Phase 1 interventional study of Darexaban and Acetyl Salicylic Acid (ASA) in Pharmacodynamic and Pharmacokinetic Interaction and Healthy Subjects, sponsored by Astellas Pharma Inc. Completed at 1 site in France. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-29.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Pharmacodynamic and Pharmacokinetic Interaction
  • Healthy Subjects

Keywords

  • Pharmacodynamics
  • pharmacokinetics
  • darexaban
  • Acetyl Salicylic Acid
  • darexaban glucuronide
  • YM150
  • YM-222714
  • Phase 1
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Treatment arm 1

    darexaban, wash-out, ASA, wash-out, darexaban plus ASA

    Drug: Darexaban · Drug: Acetyl Salicylic Acid (ASA)

  • Experimental
    Treatment arm 2

    darexaban, wash-out, darexaban plus ASA, wash-out, ASA

    Drug: Darexaban · Drug: Acetyl Salicylic Acid (ASA)

  • Experimental
    Treatment arm 3

    ASA, wash-out, darexaban, wash-out, darexaban plus ASA

    Drug: Darexaban · Drug: Acetyl Salicylic Acid (ASA)

  • Experimental
    Treatment arm 4

    ASA, wash-out, darexaban plus ASA, wash-out, darexaban

    Drug: Darexaban · Drug: Acetyl Salicylic Acid (ASA)

  • Experimental
    Treatment arm 5

    darexaban plus ASA, wash-out, darexaban, wash-out, ASA

    Drug: Darexaban · Drug: Acetyl Salicylic Acid (ASA)

  • Experimental
    Treatment arm 6

    darexaban plus ASA, wash-out, ASA, wash-out, darexaban

    Drug: Darexaban · Drug: Acetyl Salicylic Acid (ASA)

Interventions

  • DrugDarexaban

    oral

    Also known as: YM150

  • DrugAcetyl Salicylic Acid (ASA)

    oral

    Also known as: Aspirin

06

What researchers measure

Primary outcomes

  1. Composite assessment of pharmacodynamics of darexaban and darexaban glucuronide

    Assessment includes skin bleeding time, factor Xa, platelet aggregation, thromboxane B2 synthesis, PT \& aPTT

    Time frame: Baseline and after six days of dosing of darexaban, ASA, or a combination of the two

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • SGS Aster
    Paris, 75015, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01424332
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Aug 29, 2011
Start date
Dec 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Aug 29, 2011

Study contacts

Clinical Study Manager
study chair · Astellas Pharma Europe B.V.
Principal Investigator
principal investigator · SGS Aster, Paris, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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