NCT01125670CompletedPhase 1
Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet-
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 24
- Primary Endpoint
- Plasma concentration of YM150 and its metabolites measured by blood samples
Study Overview
Brief Summary
This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 44 Years (Adult)
- Sex
- Male
- Accepts 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 (INR) 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
Arms & Interventions
fast-fed sequence group
Experimental
Intervention: YM150 (Drug)
fed-fast sequence group
Experimental
Intervention: YM150 (Drug)
Outcomes
Primary Outcomes
Plasma concentration of YM150 and its metabolites measured by blood samples
Time Frame: for 3 days after drug administration
Secondary Outcomes
- Safety assessed by AEs, vital signs, 12-lead ECG and lab tests(for 3 days after drug administration)
Investigators
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