Healthy Elderly Subject, Pharmacokinetic of YM150
Conditions
Keywords
YM150, Plasma concentration, darexaban, Healthy elderly subject, Pharmacokinetics of YM150
Brief 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.
Interventions
DRUGYM150
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of YM150 assessed by its plasma concentration change | for 7 days |
| AUC of YM150 assessed by its plasma concentration change | for 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa | for 7 days |
| Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests | for 7 days |
Countries
Japan
Outcome results
None listed