A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers
- Registration Number
- NCT00965926
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests
- Body weight (at screening); female ≥40.0 kg, <70.0 kg, male ≥50.0 kg, <80.0 kg
- BMI (at screening): ≥17.6, <26.4
- Written informed consent has been obtained
Exclusion Criteria
- Received any investigational drugs within 120 days before the screening test
- 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 screening test
- Received medication within 7 days before hospital admission or is scheduled to receive medication
- Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period
- History of drug allergies
- Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low dose group YM178 3 way cross-over. Fasting, normal diet and high-fat diet High dose group YM178 3 way cross-over. Fasting, normal diet and high-fat diet
- Primary Outcome Measures
Name Time Method Plasma concentration of unchanged YM178 Up to 96 hours post dose
- Secondary Outcome Measures
Name Time Method Urinary concentration of unchanged YM178 Up to 96 hours post dose