- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01674777
A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941
August 27, 2012 updated by: Astellas Pharma Inc
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kantou, Japan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 44 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: under fasting condition group
Subjects will receive a single dose of ASP1941 under fasting condition
|
oral
Other Names:
|
Experimental: before meal group
Subjects will receive a single dose of ASP1941 before meal
|
oral
Other Names:
|
Experimental: after meal condition
Subjects will receive a single dose of ASP1941 after meal
|
oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax
Time Frame: 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)
|
For 72 hours after each administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance
Time Frame: For 72 hours after each administration
|
Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 )
|
For 72 hours after each administration
|
Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
Time Frame: For 72 hours after each administration
|
For 72 hours after each administration
|
|
Changes in urinary glucose excretion
Time Frame: Before and for 72 hours after each administration
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Before and for 72 hours after each administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 21, 2012
First Submitted That Met QC Criteria
August 27, 2012
First Posted (Estimate)
August 29, 2012
Study Record Updates
Last Update Posted (Estimate)
August 29, 2012
Last Update Submitted That Met QC Criteria
August 27, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1941-CL-0071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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