NCT01121198CompletedPhase 1
ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 84
- Primary Endpoint
- Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests
Study Overview
Brief Summary
This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.
Detailed Description
This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 44 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body weight: 50.0 kg ≤ weight < 85.0 kg
- •Body mass index:17.6 ≤ BMI < 26.4
- •Those who provided written informed consent themselves
Exclusion Criteria
- •Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
- •Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
- •Those whose lab-test results are in the abnormal range
- •Those who received medical treatment within 14 days prior to the study
- •Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study
- •Those who have received ASP1941 before
- •Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study
- •Those within a fasting plasma glucose level of < 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%
Arms & Interventions
placebo repeated arm
Placebo Comparator
Intervention: placebo (Drug)
placebo single arm
Placebo Comparator
Intervention: placebo (Drug)
ASP1941 single arm
Experimental
Intervention: ASP1941 (Drug)
ASP1941 repeated arm
Experimental
Intervention: ASP1941 (Drug)
Outcomes
Primary Outcomes
Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests
Time Frame: 72 hours after drug administration
Secondary Outcomes
- Blood glucose level measured by blood sample(72 hours after drug administration)
- Plasma concentration of unchanged drug measured by blood sample(72 hours after drug administration)
- Urinary glucose excretion level(72 hours after drug administration)
Investigators
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