A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration

Study Overview
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Brief Summary
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This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.

Detailed Description
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This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.

Official Title
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Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate

Conditions
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Healthy, Pharmacokinetics of ASP1941, Pharmacokinetics of Mitiglinide

Intervention / Treatment
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* Drug: ASP1941
* Drug: Mitiglinide calcium hydrate


Participation Criteria
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Eligibility Criteria
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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 kg/m2 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 Previous treatment with ASP1941

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>Subjects will receive ASP1941 alone and ASP1941 + Mitiglinide calcium hydrate in different orders. | Drug: ASP1941<br>* oral<br>* Other names: ipragliflozin;Drug: Mitiglinide calcium hydrate<br>* oral<br>* Other names: Glufast;|
| Experimental: Part 2<br>Subjects will receive Mitiglinide calcium hydrate alone and ASP1941 + Mitiglinide calcium hydrate in different orders. | Drug: ASP1941<br>* oral<br>* Other names: ipragliflozin;Drug: Mitiglinide calcium hydrate<br>* oral<br>* Other names: Glufast;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change |  | For up to 72 hours after each administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests |  | For up to 10 days | 
| Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change |  | For 72 hours after ASP1941 administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP1941, ipragliflozin, Mitiglinide calcium hydrate, Drug-Drug interaction, Pharmacokinetics