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

January 23, 2012 updated by: Astellas Pharma Inc

YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 79 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo group
Drug: Placebo
oral
EXPERIMENTAL: YM150 low dose group
Drug: YM150
oral
Other Names:
  • darexaban
EXPERIMENTAL: YM150 middle dose group
Drug: YM150
oral
Other Names:
  • darexaban
EXPERIMENTAL: YM150 high dose group
Drug: YM150
oral
Other Names:
  • darexaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of YM150 assessed by its plasma concentration change
Time Frame: for 7 days
for 7 days
AUC of YM150 assessed by its plasma concentration change
Time Frame: for 7 days
for 7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

February 1, 2007

Study Completion (ACTUAL)

February 1, 2007

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (ESTIMATE)

January 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2012

Last Update Submitted That Met QC Criteria

January 23, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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