Healthy Elderly Subject Clinical Trial
Official title:
YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects
| Verified date | January 2012 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | February 2007 |
| Est. primary completion date | February 2007 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 65 Years to 79 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cmax of YM150 assessed by its plasma concentration change | for 7 days | No | |
| Primary | AUC of YM150 assessed by its plasma concentration change | for 7 days | No | |
| Secondary | Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa | for 7 days | No | |
| Secondary | Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests | for 7 days | No |