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
  Purpose

This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.


Condition Intervention Phase
Healthy
Pharmacokinetics of YM150
Drug: YM150
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Plasma concentration of YM150 and its metabolites [ Time Frame: for 3 days after drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fast-fed sequence group
drug is administered in a fasted condition first, and fed-condition study follows
Drug: YM150
oral
Experimental: fed-fast sequence group
drug is administered in a fed condition first, and fasted-condition study follows
Drug: YM150
oral

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118559

Locations
Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01118559     History of Changes
Other Study ID Numbers: 150-CL-019
Study First Received: May 5, 2010
Last Updated: May 5, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM150
Food effect
Healthy volunteer

ClinicalTrials.gov processed this record on April 23, 2014