To Evaluate Whether Acetyl Salicylic Acid (Aspirin), the Combination of Aspirin and Clopidogrel and Darexaban (YM150) Interact in Their Effects

NCT01409616 | Completed Phase 1

• 2 other identifiers: 150-CL-0352007-007036-26
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate whether ASA, the combination of ASA and clopidogrel, 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.

Conditions

Pharmacodynamic Interaction; Healthy Subjects

Keywords

Pharmacodynamics; darexaban; Acetyl Salicylic Acid; clopidogrel; YM150; Phase 1

Outcome Measures

Primary Outcomes (1)

• Assessment of pharmacodynamics of darexaban

  Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination

Secondary Outcomes (3)

• Assessment of pharmacodynamics of ASA and a combination of ASA and clopidogrel

  Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination

• Pharmacokinetics of ASA and the combination of ASA and clopidogrel assessed by plasma concentration

  Plasma samples are taken until 24 hours after six days of dosing of ASA, a combination of ASA and clopidogrel, or the combination with darexaban

• Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events

  6 days for each of the 2 treatment periods

Study Arms (8)

Treatment arm A

EXPERIMENTAL

ASA, wash-out (w.o.), ASA + darexaban

Drug: darexaban; Drug: Acetyl Salicylic Acid

Treatment arm B

EXPERIMENTAL

ASA + darexaban, w.o., ASA

Drug: darexaban; Drug: Acetyl Salicylic Acid

Treatment arm C

EXPERIMENTAL

ASA, w.o., darexaban (double dose) + ASA

Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid

Treatment arm D

EXPERIMENTAL

darexaban (double dose) + ASA, w.o., ASA

Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid

Treatment arm E

EXPERIMENTAL

ASA + clopidogrel, w.o., ASA + clopidogrel + darexaban

Drug: darexaban; Drug: Acetyl Salicylic Acid; Drug: clopidogrel

Treatment arm F

EXPERIMENTAL

ASA + clopidogrel + darexaban, w.o., ASA + clopidogrel

Drug: darexaban; Drug: Acetyl Salicylic Acid; Drug: clopidogrel

Treatment arm G

EXPERIMENTAL

ASA + clopidogrel, w.o., darexaban (double dose) + ASA + clopidogrel

Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid; Drug: clopidogrel

Treatment arm H

EXPERIMENTAL

darexaban (double dose) + ASA + clopidogrel, w.o., ASA + clopidogrel

Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid; Drug: clopidogrel

Interventions

darexaban DRUG

oral

Also known as: YM150

Treatment arm A; Treatment arm B; Treatment arm E; Treatment arm F

darexaban (double dose) DRUG

oral

Also known as: YM150

Treatment arm C; Treatment arm D; Treatment arm G; Treatment arm H

Acetyl Salicylic Acid DRUG

oral

Also known as: Aspirin

Treatment arm A; Treatment arm B; Treatment arm C; Treatment arm D; Treatment arm E; Treatment arm F; Treatment arm G; Treatment arm H

clopidogrel DRUG

oral

Also known as: Plavix

Treatment arm E; Treatment arm F; Treatment arm G; Treatment arm H

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

SGS Aster

Paris, 75015, France

Location

MeSH Terms

Interventions

darexaban; Aspirin; Clopidogrel

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

• Principal Investigator

  SGS Aster, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 4, 2011
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 21, 2013

Record last verified: 2011-08

Locations

FR (1)