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Mass Balance Study of ASP1941

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ClinicalTrials.gov Identifier: NCT01302132
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Information provided by:

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Primary Completion Date : October 2008
Study Completion Date : October 2008
Arms and Interventions

Intervention Details:
    Drug: ASP1941
    Oral solution

Outcome Measures

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 ]

Eligibility Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01302132

Zuidlaren, Netherlands, 9470 AE
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Europe B.V.
More Information

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT01302132     History of Changes
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