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

Phase 1

Completed

• Conditions: Healthy; Pharmacokinetics of ASP1941
• Interventions: Drug: ASP1941

• Registration Number: NCT01674777
• Lead Sponsor: Astellas Pharma Inc

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".

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-08
• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-27
• Last Update Submitted: 2012-08-27
• Study First Posted: 2012-08-29
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
under fasting condition group	ASP1941	Subjects will receive a single dose of ASP1941 under fasting condition
before meal group	ASP1941	Subjects will receive a single dose of ASP1941 before meal
after meal condition	ASP1941	Subjects will receive a single dose of ASP1941 after meal

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax	For 72 hours after each administration	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)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance	For 72 hours after each administration	Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 )
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