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

Phase 1

Completed

• Conditions: Healthy; Pharmacokinetics of ASP1941; Pharmacokinetics of Mitiglinide
• Interventions: Drug: ASP1941; Drug: Mitiglinide calcium hydrate

• Registration Number: NCT01403818
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1	ASP1941	Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
Part 1	Mitiglinide calcium hydrate	Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
Part 2	Mitiglinide calcium hydrate	Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
Part 2	ASP1941	Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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