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

NCT ID: NCT01674777

Last Updated: 2012-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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".

Conditions

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Healthy Pharmacokinetics of ASP1941

Keywords

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ASP1941 Food effect Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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under fasting condition group

Subjects will receive a single dose of ASP1941 under fasting condition

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

before meal group

Subjects will receive a single dose of ASP1941 before meal

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

after meal condition

Subjects will receive a single dose of ASP1941 after meal

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

Interventions

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ASP1941

oral

Intervention Type DRUG

Other Intervention Names

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ipragliflozin

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
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Kantou, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1941-CL-0071

Identifier Type: -

Identifier Source: org_study_id