Completed

A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941

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What is being tested

ASP1941

+ ASP1941

+ ASP1941

Drug
Who is being recruted

From 20 to 44 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 1
Interventional
Study Start: October 2010
See protocol details

Summary

Principal SponsorAstellas Pharma Inc
Last updated: August 29, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2010

Actual date on which the first participant was enrolled.

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".

NCT01674777
Principal SponsorAstellas Pharma Inc
Last updated: August 29, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 44 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Body Mass Index ; >= 17.6, < 26.4
Body weight ; >= 50.0 kg, < 80.0 kg
Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
Written informed consent has been obtained
6 exclusion criteria prevent from participating
A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
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
History of drug allergies
Received any investigational drugs within 120 days before the screening assessment
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects will receive a single dose of ASP1941 under fasting condition

Group II

Experimental
Subjects will receive a single dose of ASP1941 before meal

Group III

Experimental
Subjects will receive a single dose of ASP1941 after meal

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kantou, JapanOpen in Google Maps
CompletedOne Study Center