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A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403818
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date October 12, 2011
Study Start Date  ICMJE June 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change [ Time Frame: For up to 72 hours after each administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests [ Time Frame: For up to 10 days ]
  • Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change [ Time Frame: For 72 hours after ASP1941 administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration
Official Title  ICMJE Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate
Brief Summary This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.
Detailed Description This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Healthy
  • Pharmacokinetics of ASP1941
  • Pharmacokinetics of Mitiglinide
Intervention  ICMJE
  • Drug: ASP1941
    oral
    Other Name: ipragliflozin
  • Drug: Mitiglinide calcium hydrate
    oral
    Other Name: Glufast
Study Arms  ICMJE
  • Experimental: Part 1
    Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
    Interventions:
    • Drug: ASP1941
    • Drug: Mitiglinide calcium hydrate
  • Experimental: Part 2
    Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
    Interventions:
    • Drug: ASP1941
    • Drug: Mitiglinide calcium hydrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2011)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 kg/m2
  • 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
  • Previous treatment with ASP1941
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403818
Other Study ID Numbers  ICMJE 1941-CL-0074
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Use Central Contact Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP