Clinical trial NCT01514825: A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects
Official title: YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Elderly Subject
Pharmacokinetic of YM150
Keywords: YM150
Plasma concentration
darexaban
Healthy elderly subject
Pharmacokinetics of YM150
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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

Primary outcomes:
measure: Cmax of YM150 assessed by its plasma concentration change
timeFrame: for 7 days
measure: AUC of YM150 assessed by its plasma concentration change
timeFrame: for 7 days
Secondary outcomes:
measure: Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa
timeFrame: for 7 days
measure: Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests
timeFrame: for 7 days
Other outcomes:
Locations:
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: