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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01118559
First received: May 5, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

May 5, 2010
May 5, 2010
November 2009
January 2010   (final data collection date for primary outcome measure)
Plasma concentration of YM150 and its metabolites [ Time Frame: for 3 days after drug administration ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Safety assessed by AEs, vital signs, 12-lead ECG and lab tests [ Time Frame: for 3 days after drug administration ] [ Designated as safety issue: No ]
  • PT (prothrombin time) [ Time Frame: for 3 days after drug administration ] [ Designated as safety issue: No ]
  • aPTT (activated partial thromboplastin time) [ Time Frame: for 2 days after drug administration ] [ Designated as safety issue: No ]
  • FXa (factor Xa) activity [ Time Frame: for 1 days after drug administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150
Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150

This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male 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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Healthy
  • Pharmacokinetics of YM150
Drug: YM150
oral
  • Experimental: fast-fed sequence group
    drug is administered in a fasted condition first, and fed-condition study follows
    Intervention: Drug: YM150
  • Experimental: fed-fast sequence group
    drug is administered in a fed condition first, and fasted-condition study follows
    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
January 2010
January 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 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
Male
20 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01118559
150-CL-019
No
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