A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects

Study Overview
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Brief Summary
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This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

Detailed Description
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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.

Official Title
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ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-

Conditions
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Healthy Volunteer, Pharmacokinetics of ASP1941

Intervention / Treatment
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* Drug: ASP1941
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1941 single arm<br> | Drug: ASP1941<br>* oral<br>|
| Experimental: ASP1941 repeated arm<br> | Drug: ASP1941<br>* oral<br>|
| Placebo Comparator: placebo single arm<br> | Drug: placebo<br>* oral<br>|
| Placebo Comparator: placebo repeated arm<br> | Drug: placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests |  | 72 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of unchanged drug measured by blood sample |  | 72 hours after drug administration | 
| Blood glucose level measured by blood sample |  | 72 hours after drug administration | 
| Urinary glucose excretion level |  | 72 hours after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food effect