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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Elderly Subject Pharmacokinetic of YM150

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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YM150 low dose group

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

oral

YM150 middle dose group

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

oral

YM150 high dose group

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

oral

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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YM150

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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darexaban

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes