HealthyPhase 1NCT01514812
A Study to Investigate the Effect of YM150 on the Plasma Concentration of Digoxin in Healthy Subjects
A Phase 1 study testing YM150 and digoxin in people with Healthy and Pharmacokinetic of Digoxin, run by Astellas Pharma Inc at 1 site in France.
Trial summary
This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetic of Digoxin
- What is being tested?
- YM150 and digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Apr 2006
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests
- Body weight: male: ≥60 kg, <100 kg; female: ≥45.0 kg, <80.0 kg
- BMI (at screening): ≥18.0, <30.0
Who cannot join
- Female subjects of child-bearing potential, not practicing adequate methods to prevent pregnancies, like abstinence or double barrier methods
- Known or suspected hypersensitivity / allergy to FXa inhibitors, digoxin, or heart glycosides in general or the constituents of the formulations used
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to neutropenia, thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular purpura, bleeding gums, or frequent nose bleeding
- Family history of congenital vascular malformation (e.g. Marfan's Syndrome) and/or bleeding disorder (e.g. hemophilia, Von Willebrand's disease, Christmas disease)
- PT or aPTT at the screening visit outside the normal range
- History of peptic ulcer or of any other organic lesion susceptible to bleed
Show all 14Show fewer
- Any surgical intervention (including tooth extraction) or trauma within the last 3 months preceding the initiation of the study
- Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to admission to the Research Unit
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- Any of the liver function tests (ALAT, ASAT, LDH and γ-GT) above the upper limit of normal range (ULN)
- Any clinically significant abnormality following the investigator's review of the prestudy physical examination, ECG and clinical laboratory tests
- Abnormal pulse rate and blood pressure measurements at the pre-study visit as follows: Pulse rate <40 or >90 bpm; systolic blood pressure <95 or >160 mmHg; diastolic blood pressure <40 or >95 mmHg (measurements taken after subject has been resting in supine position for 5 min)
- Regular use of any prescribed or OTC (over-the-counter) drugs (including natural and herbal remedies and especially those with P-gp inhibiting activity, like St. John's worth) in the four weeks prior to admission to the Research Unit OR any use of such drugs (including natural and herbal remedies) as well as vitamins in the two weeks prior to admission to the Research Unit
- Donation of blood or blood products within 3 months prior to admission to the Research Unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Two Period Crossover Study To Determine The Effect of Multiple Doses of 120 MG Modified Release Formulation of YM150 on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects
This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in healthy subjects.
Read the detailed description
The study will be of a double blind, randomized, two period crossover design. Two treatments, digoxin in combination with YM150, and digoxin in combination with placebo, will be evaluated. Each subject will receive both treatments in random order. Placebo will be used to maintain the blind. Males and females will be equally divided over the treatment orders.
Subjects will be dosed with digoxin and either YM150 or placebo for 8 days to reach steady state. In the second period the subjects will receive digoxin and the alternate treatment. There will be a washout period of at least 10 days between the consecutive treatments. In both study periods the subjects will be admitted the day prior to study drug administration (Day 0). The subjects will be discharged on Day 10. Approximately one week after the last discharge, the subjects will return to the unit for a post study visit.
- Conditions
- Healthy, Pharmacokinetic of Digoxin
- Being tested
- YM150, placebo, digoxin
- Keywords
- YM150, digoxin, drug-drug interaction, Plasma concentration, darexaban, Pharmacokinetics of digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
Also called darexaban
oral - modified release formulation of YM150
placeboDrug
oral
digoxinDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| YM150-placebo sequence group | Experimental | YM150+digoxin; Washout; Placebo+digoxin Receives: Drug: YM150; Drug: placebo; Drug: digoxin |
| placebo-YM150 sequence group | Experimental | Placebo+digoxin; Washout; YM150+digoxin Receives: Drug: YM150; Drug: placebo; Drug: digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of digoxin assessed by its plasma concentration change
Measured: for 24 hour after the last dose of each period
AUC of digoxin assessed by its plasma concentration change
Measured: for 24 hour after the last dose of each period
Secondary outcomes (2)
Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa
Measured: before dosing and 5hr after dosing on days 4 and 8 and 24h and 48h after the last dose
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests
Measured: for 10 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startFeb 2006
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514812
- Sponsor's protocol ID
- 150-CL-007
- Other IDs
- 2004-004930-15, 2004
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kadokura T, Groenendaal D, Heeringa M, Mol R, Verheggen F, Garcia-Hernandez A, Onkels H. Darexaban (YM150), an oral direct factor Xa inhibitor, has no effect on the pharmacokinetics of digoxin. Eur J Drug Metab Pharmacokinet. 2014 Mar;39(1):1-9. doi: 10.1007/s13318-013-0141-1. Epub 2013 Jun 11.
PubMed 23754514
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Two Period Crossover Study To Determine The Effect of Multiple Doses of 120 MG Modified Release Formulation of YM150 on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01514812
- Acronym / sponsor ID
- 150-CL-007
- Conditions
- Healthy, Pharmacokinetic of Digoxin
- Keywords
- YM150, digoxin, drug-drug interaction, Plasma concentration, darexaban, Pharmacokinetics of digoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 23 Jan 2012 (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.
This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in healthy subjects.
Detailed description
The study will be of a double blind, randomized, two period crossover design. Two treatments, digoxin in combination with YM150, and digoxin in combination with placebo, will be evaluated. Each subject will receive both treatments in random order. Placebo will be used to maintain the blind. Males and females will be equally divided over the treatment orders.
Subjects will be dosed with digoxin and either YM150 or placebo for 8 days to reach steady state. In the second period the subjects will receive digoxin and the alternate treatment. There will be a washout period of at least 10 days between the consecutive treatments. In both study periods the subjects will be admitted the day prior to study drug administration (Day 0). The subjects will be discharged on Day 10. Approximately one week after the last discharge, the subjects will return to the unit for a post study visit.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YM150-placebo sequence group | Experimental | Drug: YM150, Drug: placebo, Drug: digoxinYM150+digoxin; Washout; Placebo+digoxin |
| placebo-YM150 sequence group | Experimental | Drug: YM150, Drug: placebo, Drug: digoxinPlacebo+digoxin; Washout; YM150+digoxin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests
- Body weight: male: ≥60 kg, <100 kg; female: ≥45.0 kg, <80.0 kg
- BMI (at screening): ≥18.0, <30.0
Key exclusion criteria (14 listed)
- Female subjects of child-bearing potential, not practicing adequate methods to prevent pregnancies, like abstinence or double barrier methods
- Known or suspected hypersensitivity / allergy to FXa inhibitors, digoxin, or heart glycosides in general or the constituents of the formulations used
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to neutropenia, thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular purpura, bleeding gums, or frequent nose bleeding
- Family history of congenital vascular malformation (e.g. Marfan's Syndrome) and/or bleeding disorder (e.g. hemophilia, Von Willebrand's disease, Christmas disease)
- PT or aPTT at the screening visit outside the normal range
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 |
|---|---|---|
| YM150Also: darexabanoral - modified release formulation of YM150 | Drug | YM150-placebo sequence group, placebo-YM150 sequence group |
| placebooral | Drug | YM150-placebo sequence group, placebo-YM150 sequence group |
| digoxinoral | Drug | YM150-placebo sequence group, placebo-YM150 sequence group |
Primary outcome
Cmax of digoxin assessed by its plasma concentration change
Time frame: for 24 hour after the last dose of each period
AUC of digoxin assessed by its plasma concentration change
Time frame: for 24 hour after the last dose of each period
2 secondary outcomes
Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa
Time frame: before dosing and 5hr after dosing on days 4 and 8 and 24h and 48h after the last dose
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests
Time frame: for 10 days after dosing
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 24 Jan 2012.
- Derived from this study: PubMed 23754514Kadokura T, Groenendaal D, Heeringa M, Mol R, Verheggen F, Garcia-Hernandez A, Onkels H. Darexaban (YM150), an oral direct factor Xa inhibitor, has no effect on the pharmacokinetics of digoxin. Eur J Drug Metab Pharmacokinet. 2014 Mar;39(1):1-9. doi: 10.1007/s13318-013-0141-1. Epub 2013 Jun 11.
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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.
Use Central Contact study chair
Astellas Pharma Inc
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 YM150 and digoxin in people with Healthy and Pharmacokinetic of Digoxin, 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 3 inclusion and 14 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 24 Jan 2012. 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?
Cmax of digoxin assessed by its plasma concentration change (time frame: for 24 hour after the last dose of each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01514812, which also lists 1 linked publication.
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 24 Jan 2012.