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Completed

NCT Number: NCT01514825

A Study to Investigate the Plasma Concentration of YM150 After Repeated 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.

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Key information

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyushu, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM150

Drug

oral

Other names: darexaban

Placebo

Drug

oral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

YM150 Clinical Pharmacology Study - Repeated Oral Administration to Elderly Subjects

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 23, 2012
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.