A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
65 Years to 79 Years (Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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 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]