Healthy, Pharmacokinetics of YM150
Conditions
Keywords
YM150, Food effect, Healthy volunteer
Brief summary
This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.
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.
Interventions
DRUGYM150
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of YM150 and its metabolites | for 3 days after drug administration |
Secondary
| Measure | 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 |
Countries
Japan
Outcome results
None listed