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

NCT01514825 | Completed Phase 1

• 1 other identifier: 150-CL-026
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Elderly Subject; Pharmacokinetic of YM150

Keywords

YM150; Plasma concentration; darexaban; Healthy elderly subject; Pharmacokinetics of YM150

Outcome Measures

Primary Outcomes (2)

• Cmax of YM150 assessed by its plasma concentration change

  for 7 days

• AUC of YM150 assessed by its plasma concentration change

  for 7 days

Secondary Outcomes (2)

• Changes in the blood coaggregation indexes such as PT(INR), aPTT and FXa

  for 7 days

• Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests

  for 7 days

Study Arms (4)

YM150 low dose group

EXPERIMENTAL

Drug: YM150

YM150 middle dose group

EXPERIMENTAL

Drug: YM150

YM150 high dose group

EXPERIMENTAL

Drug: YM150

placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

YM150 DRUG

oral

Also known as: darexaban

YM150 high dose group; YM150 low dose group; YM150 middle dose group

Placebo DRUG

oral

placebo group

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

MeSH Terms

Interventions

darexaban

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 23, 2012
• Study Start: November 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

JP (1)