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

Phase 1

Completed

• Conditions: Pharmacodynamic and Pharmacokinetic Interaction; Healthy Subjects
• Interventions: Drug: Darexaban; Drug: Acetyl Salicylic Acid (ASA)

• Registration Number: NCT01424332
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2011-08
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-25
• Last Update Submitted: 2011-08-25
• Study First Posted: 2011-08-29
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment arm 1	Acetyl Salicylic Acid (ASA)	darexaban, wash-out, ASA, wash-out, darexaban plus ASA
Treatment arm 2	Acetyl Salicylic Acid (ASA)	darexaban, wash-out, darexaban plus ASA, wash-out, ASA
Treatment arm 3	Acetyl Salicylic Acid (ASA)	ASA, wash-out, darexaban, wash-out, darexaban plus ASA
Treatment arm 4	Acetyl Salicylic Acid (ASA)	ASA, wash-out, darexaban plus ASA, wash-out, darexaban
Treatment arm 5	Darexaban	darexaban plus ASA, wash-out, darexaban, wash-out, ASA
Treatment arm 5	Acetyl Salicylic Acid (ASA)	darexaban plus ASA, wash-out, darexaban, wash-out, ASA
Treatment arm 6	Darexaban	darexaban plus ASA, wash-out, ASA, wash-out, darexaban
Treatment arm 6	Acetyl Salicylic Acid (ASA)	darexaban plus ASA, wash-out, ASA, wash-out, darexaban
Treatment arm 4	Darexaban	ASA, wash-out, darexaban plus ASA, wash-out, darexaban
Treatment arm 1	Darexaban	darexaban, wash-out, ASA, wash-out, darexaban plus ASA
Treatment arm 2	Darexaban	darexaban, wash-out, darexaban plus ASA, wash-out, ASA
Treatment arm 3	Darexaban	ASA, wash-out, darexaban, wash-out, darexaban plus ASA

Primary Outcome Measures

Name	Time	Method
Composite assessment of pharmacodynamics of darexaban and darexaban glucuronide	Baseline and after six days of dosing of darexaban, ASA, or a combination of the two	Assessment includes skin bleeding time, factor Xa, platelet aggregation, thromboxane B2 synthesis, PT \& aPTT

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of darexaban and darexaban glucuronide assessed by plasma concentration	Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with ASA
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events	6 days for each of the 3 treatment periods
Pharmacokinetics of ASA assessed by plasma concentration	Plasma samples are taken until 2 hours after six days of dosing of ASA, or the combination with darexaban

Trial Locations

Locations (1)

SGS Aster; 🇫🇷 Paris, France