A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects

Study Overview
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Brief Summary
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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.

Official Title
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YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects

Conditions
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Healthy Elderly Subject, Pharmacokinetic of YM150

Intervention / Treatment
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* Drug: YM150
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM150 low dose group<br> | Drug: YM150<br>* oral<br>* Other names: darexaban;|
| Experimental: YM150 middle dose group<br> | Drug: YM150<br>* oral<br>* Other names: darexaban;|
| Experimental: YM150 high dose group<br> | Drug: YM150<br>* oral<br>* Other names: darexaban;|
| Placebo Comparator: placebo group<br> | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YM150, Plasma concentration, darexaban, Healthy elderly subject, Pharmacokinetics of YM150