Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT01288898
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Body weight between 60-100kg, body mass index (BMI) between 20-30 kg/m2, inclusive
Exclusion Criteria
- Fasting Plasma Glucose (FPG) > 6.4 mmol/l
- HbA1c > 6.2%
- Abnormal pulse of blood pressure at screening, as judged by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests 31 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetics assessed by the ASP1941 plasma concentration change up to 96 hours after last dose Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine up to 96 hours after last dose