Status:
COMPLETED
A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy Elderly Subject
Pharmacokinetic of YM150
Eligibility:
All Genders
65-79 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01514825
Start Date
November 1 2006
End Date
February 1 2007
Last Update
January 24 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kyushu, Japan