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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514825
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 24, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Elderly Subject Pharmacokinetic of YM150 Drug: YM150 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects
Study Start Date : November 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Arm Intervention/treatment
Experimental: YM150 low dose group Drug: YM150
Other Name: darexaban

Experimental: YM150 middle dose group Drug: YM150
Other Name: darexaban

Experimental: YM150 high dose group Drug: YM150
Other Name: darexaban

Placebo Comparator: placebo group Drug: Placebo

Primary Outcome Measures :
  1. Cmax of YM150 assessed by its plasma concentration change [ Time Frame: for 7 days ]
  2. AUC of YM150 assessed by its plasma concentration change [ Time Frame: for 7 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514825

Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc Identifier: NCT01514825     History of Changes
Other Study ID Numbers: 150-CL-026
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action