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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01514825
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Healthy Elderly Subject
Pharmacokinetic of YM150
Drug: YM150
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Cmax of YM150 assessed by its plasma concentration change [ Time Frame: for 7 days ] [ Designated as safety issue: No ]
  • AUC of YM150 assessed by its plasma concentration change [ Time Frame: for 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa [ Time Frame: for 7 days ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests [ Time Frame: for 7 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM150 low dose group Drug: YM150
oral
Other Name: darexaban
Experimental: YM150 middle dose group Drug: YM150
oral
Other Name: darexaban
Experimental: YM150 high dose group Drug: YM150
oral
Other Name: darexaban
Placebo Comparator: placebo group Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   65 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514825

Locations
Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01514825     History of Changes
Other Study ID Numbers: 150-CL-026
Study First Received: January 18, 2012
Last Updated: January 23, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM150
Plasma concentration
darexaban
Healthy elderly subject
Pharmacokinetics of YM150

ClinicalTrials.gov processed this record on July 29, 2014