A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.

Detailed Description
-----------------
This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 under fasting condition, before meal and after meal.

Official Title
-----------------
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941

Conditions
-----------------
Healthy, Pharmacokinetics of ASP1941

Intervention / Treatment
-----------------
* Drug: ASP1941


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests Body weight ; ≥50.0 kg, <80.0 kg Body Mass Index ; ≥17.6, <26.4 Written informed consent has been obtained Exclusion Criteria: Received any investigational drugs 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 d components within 14 days before the screening assessment Received medication within 7 days before hospital admission A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission History of drug allergies With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: under fasting condition group<br>Subjects will receive a single dose of ASP1941 under fasting condition | Drug: ASP1941<br>* oral<br>* Other names: ipragliflozin;|
| Experimental: before meal group<br>Subjects will receive a single dose of ASP1941 before meal | Drug: ASP1941<br>* oral<br>* Other names: ipragliflozin;|
| Experimental: after meal condition<br>Subjects will receive a single dose of ASP1941 after meal | Drug: ASP1941<br>* oral<br>* Other names: ipragliflozin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax | Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax) | For 72 hours after each administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance | Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ) | For 72 hours after each administration | 
| Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests |  | For 72 hours after each administration | 
| Changes in urinary glucose excretion |  | Before and for 72 hours after each administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1941, Food effect, Pharmacokinetics