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

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ClinicalTrials.gov Identifier: NCT01118559
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : May 6, 2010
Sponsor:
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Healthy Pharmacokinetics of YM150 Drug: YM150 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150
Study Start Date : November 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Plasma concentration of YM150 and its metabolites [ Time Frame: for 3 days after drug administration ]

Secondary Outcome Measures :
  1. Safety assessed by AEs, vital signs, 12-lead ECG and lab tests [ Time Frame: for 3 days after drug administration ]
  2. PT (prothrombin time) [ Time Frame: for 3 days after drug administration ]
  3. aPTT (activated partial thromboplastin time) [ Time Frame: for 2 days after drug administration ]
  4. FXa (factor Xa) activity [ Time Frame: for 1 days after drug administration ]


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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118559


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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01118559     History of Changes
Other Study ID Numbers: 150-CL-019
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: May 6, 2010
Last Verified: May 2010

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

Additional relevant MeSH terms:
Darexaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants