Status:
COMPLETED
A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy
Pharmacokinetics of ASP0456
Eligibility:
All Genders
20-44 years
Phase:
PHASE1
Brief Summary
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postpr...
Eligibility Criteria
Inclusion
- Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01427387
Start Date
June 1 2011
End Date
September 1 2011
Last Update
September 23 2011
Active Locations (1)
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1
Kantou, Japan