Pharmacodynamic InteractionPhase 1NCT01409616
To Evaluate Whether Acetyl Salicylic Acid (Aspirin), the Combination of Aspirin and Clopidogrel and Darexaban (YM150) Interact in Their Effects
A Phase 1 study testing darexaban, darexaban (double dose) and Acetyl Salicylic Acid in people with Pharmacodynamic Interaction and Healthy Subjects, run by Astellas Pharma Inc at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamic Interaction, Healthy Subjects
- What is being tested?
- darexaban, darexaban (double dose) and Acetyl Salicylic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Two-period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Effect of Darexaban (YM150) on Acetyl Salicylic Acid (ASA) and of Darexaban on the Combination of ASA and Clopidogrel at Steady State
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
- Being tested
- darexaban, darexaban (double dose), Acetyl Salicylic Acid, clopidogrel
- Keywords
- Pharmacodynamics, darexaban, Acetyl Salicylic Acid, clopidogrel, YM150, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darexabanDrug
Also called YM150
oral
darexaban (double dose)Drug
Also called YM150
oral
Acetyl Salicylic AcidDrug
Also called Aspirin
oral
clopidogrelDrug
Also called Plavix
oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm A | Experimental | ASA, wash-out (w.o.), ASA + darexaban Receives: Drug: darexaban; Drug: Acetyl Salicylic Acid |
| Treatment arm B | Experimental | ASA + darexaban, w.o., ASA Receives: Drug: darexaban; Drug: Acetyl Salicylic Acid |
| Treatment arm C | Experimental | ASA, w.o., darexaban (double dose) + ASA Receives: Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid |
| Treatment arm D | Experimental | darexaban (double dose) + ASA, w.o., ASA Receives: Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid |
| Treatment arm E | Experimental | ASA + clopidogrel, w.o., ASA + clopidogrel + darexaban Receives: Drug: darexaban; Drug: Acetyl Salicylic Acid; Drug: clopidogrel |
| Treatment arm F | Experimental | ASA + clopidogrel + darexaban, w.o., ASA + clopidogrel Receives: Drug: darexaban; Drug: Acetyl Salicylic Acid; Drug: clopidogrel |
| Treatment arm G | Experimental | ASA + clopidogrel, w.o., darexaban (double dose) + ASA + clopidogrel Receives: Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid; Drug: clopidogrel |
| Treatment arm H | Experimental | darexaban (double dose) + ASA + clopidogrel, w.o., ASA + clopidogrel Receives: Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid; Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacodynamics of darexaban
Measured: 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
Measured: 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
Measured: 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
Measured: 6 days for each of the 2 treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacodynamic InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.Principal Investigator, Principal investigator, SGS Aster, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409616
- Sponsor's protocol ID
- 150-CL-035
- Other IDs
- 2007-007036-26
- Status last verified
- Aug 2011
- First submitted
- 1 Aug 2011
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Effect of Darexaban (YM150) on Acetyl Salicylic Acid (ASA) and of Darexaban on the Combination of ASA and Clopidogrel at Steady State
- ClinicalTrials.gov ID
- NCT01409616
- Acronym / sponsor ID
- 150-CL-035
- Conditions
- Pharmacodynamic Interaction, Healthy Subjects
- Keywords
- Pharmacodynamics, darexaban, Acetyl Salicylic Acid, clopidogrel, YM150, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Treatment arm A | Experimental | Drug: darexaban, Drug: Acetyl Salicylic AcidASA, wash-out (w.o.), ASA + darexaban |
| Treatment arm B | Experimental | Drug: darexaban, Drug: Acetyl Salicylic AcidASA + darexaban, w.o., ASA |
| Treatment arm C | Experimental | Drug: darexaban (double dose), Drug: Acetyl Salicylic AcidASA, w.o., darexaban (double dose) + ASA |
| Treatment arm D | Experimental | Drug: darexaban (double dose), Drug: Acetyl Salicylic Aciddarexaban (double dose) + ASA, w.o., ASA |
| Treatment arm E | Experimental | Drug: darexaban, Drug: Acetyl Salicylic Acid, Drug: clopidogrelASA + clopidogrel, w.o., ASA + clopidogrel + darexaban |
| Treatment arm F | Experimental | Drug: darexaban, Drug: Acetyl Salicylic Acid, Drug: clopidogrelASA + clopidogrel + darexaban, w.o., ASA + clopidogrel |
| Treatment arm G | Experimental | Drug: darexaban (double dose), Drug: Acetyl Salicylic Acid, Drug: clopidogrelASA + clopidogrel, w.o., darexaban (double dose) + ASA + clopidogrel |
| Treatment arm H | Experimental | Drug: darexaban (double dose), Drug: Acetyl Salicylic Acid, Drug: clopidogreldarexaban (double dose) + ASA + clopidogrel, w.o., ASA + clopidogrel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| darexabanAlso: YM150oral | Drug | Treatment arm A, Treatment arm B, Treatment arm E, Treatment arm F |
| darexaban (double dose)Also: YM150oral | Drug | Treatment arm C, Treatment arm D, Treatment arm G, Treatment arm H |
| Acetyl Salicylic AcidAlso: Aspirinoral | Drug | Treatment arm A, Treatment arm B, Treatment arm C, Treatment arm D, Treatment arm E, Treatment arm F, Treatment arm G, Treatment arm H |
| clopidogrelAlso: Plavixoral | Drug | Treatment arm E, Treatment arm F, Treatment arm G, Treatment arm H |
Primary outcome
Assessment of pharmacodynamics of darexaban
Time frame: Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination
3 secondary outcomes
Assessment of pharmacodynamics of ASA and a combination of ASA and clopidogrel
Time frame: 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
Time frame: 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
Time frame: 6 days for each of the 2 treatment periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
Principal Investigator principal investigator
SGS Aster, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing darexaban, darexaban (double dose) and Acetyl Salicylic Acid in people with Pharmacodynamic Interaction and Healthy Subjects, run by Astellas Pharma Inc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pharmacodynamics of darexaban (time frame: Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.