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A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01099839
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
1.9
Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in healthy adult male volunteers. Each subject will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol".

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: one group

Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.

Drug: ASP1941
oral

Drug: Miglitol
oral
Other Names:
  • Seibule

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples [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 blood 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

    • Previous treatment with ASP1941

    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:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01099839
    Other Study ID Numbers:
    • 1941-CL-0062
    First Posted:
    Apr 8, 2010
    Last Update Posted:
    Jun 9, 2010
    Last Verified:
    Jun 1, 2010
    Keywords provided by , ,
    ASP1941
    Miglitol
    Additional relevant MeSH terms:
    Ipragliflozin
    Miglitol

    Study Results

    No Results Posted as of Jun 9, 2010