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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01403818

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

29.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Pharmacokinetics of ASP1941 Pharmacokinetics of Mitiglinide	Drug: ASP1941 Drug: Mitiglinide calcium hydrate	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.	Drug: ASP1941 oral Other Names: ipragliflozin Drug: Mitiglinide calcium hydrate oral Other Names: Glufast
Experimental: Part 2 Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.	Drug: ASP1941 oral Other Names: ipragliflozin Drug: Mitiglinide calcium hydrate oral Other Names: Glufast

Arm

Intervention/Treatment

Experimental: Part 1

Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.

Drug: ASP1941

oral

Other Names:

ipragliflozin

Drug: Mitiglinide calcium hydrate

oral

Other Names:

Glufast

Experimental: Part 2

Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.

Drug: ASP1941

oral

Other Names:

ipragliflozin

Drug: Mitiglinide calcium hydrate

oral

Other Names:

Glufast

Outcome Measures

Primary Outcome Measures

Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change [For up to 72 hours after each administration]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 44 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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