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

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

Detailed Description
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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.

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

Conditions
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Healthy, Pharmacokinetics of YM150

Intervention / Treatment
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* Drug: YM150


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fast-fed sequence group<br>drug is administered in a fasted condition first, and fed-condition study follows | Drug: YM150<br>* oral<br>|
| Experimental: fed-fast sequence group<br>drug is administered in a fed condition first, and fasted-condition study follows | Drug: YM150<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of YM150 and its metabolites |  | for 3 days after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by AEs, vital signs, 12-lead ECG and lab tests |  | for 3 days after drug administration | 
| PT (prothrombin time) |  | for 3 days after drug administration | 
| aPTT (activated partial thromboplastin time) |  | for 2 days after drug administration | 
| FXa (factor Xa) activity |  | for 1 days after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YM150, Food effect, Healthy volunteer