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

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:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Aspirin Salicylic acid

U.S. FDA Resources

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 May 16, 2013