Pharmacodynamic InteractionPhase 1NCT01409603
To Evaluate Whether Naproxen and Darexaban (YM150) Interact in Their Effects
A Phase 1 study testing darexaban and Naproxen 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 naproxen 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamic Interaction, Healthy Subjects
- What is being tested?
- darexaban and Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to May 2010
- 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 55 years
- Men only
- Healthy volunteers accepted
- 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 naproxen or any components of the formulation used
- A contra-indication for the use of naproxen
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Randomized 3-Period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Interactions Between YM150 on Naproxen at Steady-State
The primary objective of this study is to evaluate whether naproxen 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, Naproxen
- Keywords
- Pharmacodynamics, darexaban, naproxen, 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
NaproxenDrug
Also called Naprosyne
oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm A | Experimental | darexaban, wash-out, naproxen, wash-out, combination therapy Receives: Drug: darexaban; Drug: Naproxen |
| Treatment arm B | Experimental | darexaban, wash-out, combination therapy, wash-out, naproxen Receives: Drug: darexaban; Drug: Naproxen |
| Treatment arm C | Experimental | naproxen, wash-out, darexaban, wash-out, combination therapy Receives: Drug: darexaban; Drug: Naproxen |
| Treatment arm D | Experimental | naproxen, wash-out, combination therapy, wash-out, darexaban Receives: Drug: darexaban; Drug: Naproxen |
| Treatment arm E | Experimental | combination therapy, wash-out, naproxen, wash-out, darexaban Receives: Drug: darexaban; Drug: Naproxen |
| Treatment arm F | Experimental | combination therapy, wash-out, darexaban, wash-out, naproxen Receives: Drug: darexaban; Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacodynamics of naproxen
Measured: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
Secondary outcomes (4)
Assessment of pharmacodynamics of darexaban
Measured: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
Pharmacokinetics of darexaban assessed by plasma concentration
Measured: Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with naproxen
Pharmacokinetics of naproxen assessed by plasma concentration
Measured: Plasma samples are taken until 12 hours after four days of dosing of naproxen, 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 treatment periods with darexaban) or 4 days. (naproxen alone)
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 startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
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
- 26 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
- NCT01409603
- Sponsor's protocol ID
- 150-CL-039
- Other IDs
- 2009-015762-64, 2009
- Status last verified
- Apr 2013
- First submitted
- 1 Aug 2011
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Randomized 3-Period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Interactions Between YM150 on Naproxen at Steady-State
- ClinicalTrials.gov ID
- NCT01409603
- Acronym / sponsor ID
- 150-CL-039
- Conditions
- Pharmacodynamic Interaction, Healthy Subjects
- Keywords
- Pharmacodynamics, darexaban, naproxen, YM150, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (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 naproxen 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
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment arm A | Experimental | Drug: darexaban, Drug: Naproxendarexaban, wash-out, naproxen, wash-out, combination therapy |
| Treatment arm B | Experimental | Drug: darexaban, Drug: Naproxendarexaban, wash-out, combination therapy, wash-out, naproxen |
| Treatment arm C | Experimental | Drug: darexaban, Drug: Naproxennaproxen, wash-out, darexaban, wash-out, combination therapy |
| Treatment arm D | Experimental | Drug: darexaban, Drug: Naproxennaproxen, wash-out, combination therapy, wash-out, darexaban |
| Treatment arm E | Experimental | Drug: darexaban, Drug: Naproxencombination therapy, wash-out, naproxen, wash-out, darexaban |
| Treatment arm F | Experimental | Drug: darexaban, Drug: Naproxencombination therapy, wash-out, darexaban, wash-out, naproxen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- 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 (10 listed)
- Known or suspected hypersensitivity to darexaban or naproxen or any components of the formulation used
- A contra-indication for the use of naproxen
- 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
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 C, Treatment arm D, Treatment arm E, Treatment arm F |
| NaproxenAlso: Naprosyneoral | Drug | Treatment arm A, Treatment arm B, Treatment arm C, Treatment arm D, Treatment arm E, Treatment arm F |
Primary outcome
Assessment of pharmacodynamics of naproxen
Time frame: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
4 secondary outcomes
Assessment of pharmacodynamics of darexaban
Time frame: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
Pharmacokinetics of darexaban assessed by plasma concentration
Time frame: Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with naproxen
Pharmacokinetics of naproxen assessed by plasma concentration
Time frame: Plasma samples are taken until 12 hours after four days of dosing of naproxen, 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 treatment periods with darexaban) or 4 days. (naproxen alone)
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 11 Apr 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 and Naproxen 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 10 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 11 Apr 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 naproxen (time frame: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two). 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 11 Apr 2013.