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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01674777
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
2
Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: under fasting condition group

Subjects will receive a single dose of ASP1941 under fasting condition

Drug: ASP1941
oral
Other Names:
  • ipragliflozin

    		•
    Experimental: before meal group

    Subjects will receive a single dose of ASP1941 before meal

    Drug: ASP1941
    oral
    Other Names:
  • ipragliflozin

    		•
    Experimental: after meal condition

    Subjects will receive a single dose of ASP1941 after meal

    Drug: ASP1941
    oral
    Other Names:
  • ipragliflozin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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 )

    2. Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests [For 72 hours after each administration]

    3. Changes in urinary glucose excretion [Before and for 72 hours after each administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 44 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kantou Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01674777
    Other Study ID Numbers:
    • 1941-CL-0071
    First Posted:
    Aug 29, 2012
    Last Update Posted:
    Aug 29, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Astellas Pharma Inc
    ASP1941
    Food effect
    Pharmacokinetics
    Additional relevant MeSH terms:
    Ipragliflozin

    Study Results

    No Results Posted as of Aug 29, 2012