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Mass Balance Study of ASP1941

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. Identifier: NCT01302132
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Information provided by:
Astellas Pharma Inc

Brief Summary:
This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: ASP1941 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open Label Study to Evaluate the Pharmacokinetics of ASP1941 After a Single Oral Dose of 14C-labeled ASP1941 in Healthy Male Subjects
Study Start Date : May 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Intervention Details:
  • Drug: ASP1941
    Oral solution

Primary Outcome Measures :
  1. Pharmacokinetics of ASP1941 to evaluate metabolism and excretion [ Time Frame: up to 216 hours ]

Secondary Outcome Measures :
  1. Identification of metabolic profile of ASP1941 [ Time Frame: up to 216 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive

Exclusion Criteria:

  • Pulse <40 or >90 bpm; Systolic Blood Pressure > 140 mmHg; Diastolic Blood Pressure >90 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01302132

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Zuidlaren, Netherlands, 9470 AE
Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Use Central Contact Astellas Pharma Europe B.V.
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Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV Identifier: NCT01302132    
Other Study ID Numbers: 1941-CL-0055
2008-000316-33 ( EudraCT Number )
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011
Keywords provided by Astellas Pharma Inc:
Mass Balance
Additional relevant MeSH terms:
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Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs