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Mass Balance Study of ASP1941

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302132
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
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.
Information provided by:
Astellas Pharma Inc
  Purpose
This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.

Condition Intervention Phase
Healthy Subjects Drug: ASP1941 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Astellas Pharma Inc:

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

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

Enrollment: 6
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ASP1941
    Oral solution
  Eligibility

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
Criteria

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


Locations
Netherlands
Zuidlaren, Netherlands, 9470 AE
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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 Submitted: February 21, 2011
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
Last Verified: February 2011

Keywords provided by Astellas Pharma Inc:
Mass Balance
ASP1941
Pharmacokinetics