We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01125670
First Posted: May 18, 2010
Last Update Posted: May 25, 2010
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.
Information provided by:
Astellas Pharma Inc
May 17, 2010
May 18, 2010
May 25, 2010
February 2010
April 2010   (Final data collection date for primary outcome measure)
Plasma concentration of YM150 and its metabolites measured by blood samples [ Time Frame: for 3 days after drug administration ]
Same as current
Complete list of historical versions of study NCT01125670 on ClinicalTrials.gov Archive Site
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests [ Time Frame: for 3 days after drug administration ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet
Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet-
This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make adult subjects.
To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
  • Healthy Volunteer
  • Pharmacokinetics of YM150
Drug: YM150
oral
  • Experimental: fast-fed sequence group
    Intervention: Drug: YM150
  • Experimental: fed-fast sequence group
    Intervention: Drug: YM150
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body weight: ≥50.0 kg, <80.0 kg
  • BMI: ≥17.6, <26.4
  • Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests

Exclusion Criteria:

  • Received any investigational drugs within 120 days before the study
  • 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 study
  • Received medication within 7 days before the study
  • A deviation from the assessment criteria of physical examinations or laboratory tests
  • A deviation from the normal reference range of coagulation test [PT (INR) or aPTT]
  • History of drug allergies
  • Upper gastrointestinal disease within 7 days before the study
  • Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
  • Concurrent or previous malignant tumor
  • Previous treatment with YM150
Sexes Eligible for Study: Male
20 Years to 44 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01125670
150-CL-047
No
Not Provided
Not Provided
Director, Astellas Pharma, Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
May 2010

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