Status:
COMPLETED
Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-44 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single or multiple oral administration in healthy non-elderly adult male subjects.
Detailed Description
The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.
Eligibility Criteria
Inclusion
- Body weight: ≥50.0 kg, \<80.0 kg
- BMI: ≥18.5 kg/m2, \<25.0 kg/m2
- Eligible, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and up to the timing immediately before study medication
- Supine blood pressure: Systolic blood pressure ≥90 mmHg, ≤130 mmHg; Diastolic blood pressure ≤85 mmHg
- Pulse rate at rest in supine position: ≥40 bpm, \<100 bpm
Exclusion
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment
- 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 assessment
- Received medication within 7 days before hospital admission or is scheduled to receive medication
- History of drug allergies
- Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study
- Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day, smoking: 20 cigarettes/day)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00978198
Start Date
September 1 2009
End Date
June 1 2010
Last Update
June 22 2010
Active Locations (1)
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1
Kantou, Japan