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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

January 18, 2012
January 23, 2012
November 2006
February 2007   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01514825 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Healthy Elderly Subject
  • Pharmacokinetic of YM150
  • Drug: YM150
    oral
    Other Name: darexaban
  • Drug: Placebo
    oral
  • Experimental: YM150 low dose group
    Intervention: Drug: YM150
  • Experimental: YM150 middle dose group
    Intervention: Drug: YM150
  • Experimental: YM150 high dose group
    Intervention: Drug: YM150
  • Placebo Comparator: placebo group
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
65 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01514825
150-CL-026
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP