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

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy Elderly Subject

Pharmacokinetic of YM150

Treatments

Drug: Placebo

Drug: YM150

Study type

Interventional

Funder types

Industry

Identifiers

NCT01514825

150-CL-026

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

65 to 79 years old

Volunteers

Accepts Healthy Volunteers

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