A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects
- Registration Number
- NCT01279915
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
- Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
- Body weight (at screening); ≥50.0 kg,<80.0 kg
- BMI(at screening): ≥17.6,<26.4
Exclusion Criteria
- Received any investigational drugs in other clinical or post-marketing studies 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 10 days before dose is administered or is scheduled to receive medication
- History of drug allergies
- Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
- Concurrent or previous hepatic disease
- Concurrent or previous heart disease
- Concurrent or previous renal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP group ASP0456 ASP0456 receiving group Placebo group Placebo Placebo treatment
- Primary Outcome Measures
Name Time Method Pharmacokinetics of ASP0456 assessed by its plasma concentration change For 48 hours after dosing
- Secondary Outcome Measures
Name Time Method Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests For 48 hours after dosing