Healthy Elderly SubjectPhase 1NCT01514825
A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects
A Phase 1 study testing YM150 in people with Healthy Elderly Subject and Pharmacokinetic of YM150, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects. Read more about this study
- Who is it for?
- Ages 65 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly Subject, Pharmacokinetic of YM150
- What is being tested?
- YM150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2006to Feb 2007
- 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 65 to 79 years
- All sexes
- Healthy volunteers accepted
- Older 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: ≥45.0 kg, <85.0 kg; female: ≥40.0 kg, <75.0 kg
- BMI (at screening): ≥17.6, <30.0
Who cannot join
- Use of any other investigational drug in another clinical study or a post-marketing clinical study within 120 days before the administration of the study drug
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment.
- Any surgical intervention (including tooth extraction) or trauma within 90 days before hospitalization until the administration, or plan of any surgical intervention within 10 week after the final administration
- A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG
- PT or aPTT on blood coagulation tests outside the upper or lower reference limits (PT: 9.9 to 15.4 sec.; aPTT: 22.5 to 49.5 sec.)
- Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study
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- Concurrent or previous hepatic disease (e.g. viral hepatitis, drug-induced liver injury)
- Concurrent or previous heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring treatment)
- Concurrent or previous respiratory disease (e.g. serious bronchial asthma, chronic bronchitis; except for a history of childhood asthma)
- Concurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis; except for a history of calculus)
- Concurrent or previous malignant tumor
- Excessive smoking or drinking habit [measure of "excessive": alcohol: average 45 g/day (a 633 mL bottle of beer contains 25 g of alcohol, and 180 mL of Japanese sake contains 22 g of alcohol), smoking: average 20 cigarettes/day]
- Previous treatment with YM150
Trial locations and contacts
1 site in 1 country.
About this study
Official title: YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects
The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects.
- Conditions
- Healthy Elderly Subject, Pharmacokinetic of YM150
- Being tested
- YM150, Placebo
- Keywords
- YM150, Plasma concentration, darexaban, Healthy elderly subject, Pharmacokinetics of YM150
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
Also called darexaban
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| YM150 low dose group | Experimental | Not described Receives: Drug: YM150 |
| YM150 middle dose group | Experimental | Not described Receives: Drug: YM150 |
| YM150 high dose group | Experimental | Not described Receives: Drug: YM150 |
| placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of YM150 assessed by its plasma concentration change
Measured: for 7 days
AUC of YM150 assessed by its plasma concentration change
Measured: for 7 days
Secondary outcomes (2)
Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa
Measured: for 7 days
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests
Measured: for 7 days
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 startNov 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elderly SubjectStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT01514825
- Sponsor's protocol ID
- 150-CL-026
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
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
- YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects
- ClinicalTrials.gov ID
- NCT01514825
- Acronym / sponsor ID
- 150-CL-026
- Conditions
- Healthy Elderly Subject, Pharmacokinetic of YM150
- Keywords
- YM150, Plasma concentration, darexaban, Healthy elderly subject, Pharmacokinetics of YM150
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (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.
The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YM150 low dose group | Experimental | Drug: YM150 |
| YM150 middle dose group | Experimental | Drug: YM150 |
| YM150 high dose group | Experimental | Drug: YM150 |
| placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older 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: ≥45.0 kg, <85.0 kg; female: ≥40.0 kg, <75.0 kg
- BMI (at screening): ≥17.6, <30.0
Key exclusion criteria (13 listed)
- Use of any other investigational drug in another clinical study or a post-marketing clinical study within 120 days before the administration of the study drug
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment.
- Any surgical intervention (including tooth extraction) or trauma within 90 days before hospitalization until the administration, or plan of any surgical intervention within 10 week after the final administration
- A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG
- PT or aPTT on blood coagulation tests outside the upper or lower reference limits (PT: 9.9 to 15.4 sec.; aPTT: 22.5 to 49.5 sec.)
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 | Drug | YM150 high dose group, YM150 low dose group, YM150 middle dose group |
| Placebooral | Drug | placebo group |
Primary outcome
Cmax of YM150 assessed by its plasma concentration change
Time frame: for 7 days
AUC of YM150 assessed by its plasma concentration change
Time frame: for 7 days
2 secondary outcomes
Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa
Time frame: for 7 days
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests
Time frame: for 7 days
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.
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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 in people with Healthy Elderly Subject and Pharmacokinetic of YM150, run by Astellas Pharma Inc at 1 site in Japan.
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 13 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 Japan. 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. Some participants in this study may receive a placebo. 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 YM150 assessed by its plasma concentration change (time frame: for 7 days). 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?
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.