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

Phase 1

Completed

• Conditions: Pharmacokinetic of YM150; Healthy Elderly Subject
• Interventions: Drug: YM150; Drug: Placebo

• Registration Number: NCT01514825
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Last Update Submitted: 2012-01-23
• Last Update Posted: 2012-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YM150 low dose group	YM150	-
YM150 middle dose group	YM150	-
placebo group	Placebo	-
YM150 high dose group	YM150	-

Primary Outcome Measures

Name	Time	Method
Cmax of YM150 assessed by its plasma concentration change	for 7 days
AUC of YM150 assessed by its plasma concentration change	for 7 days

Secondary Outcome Measures

Name	Time	Method
Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa	for 7 days
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests	for 7 days