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Mass Balance Study of ASP1941

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01302132
First received: February 21, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification of metabolic profile of ASP1941 [ Time Frame: up to 216 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302132

Locations
Netherlands
Zuidlaren, Netherlands, 9470 AE
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe BV
  More Information

No publications provided

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
Study First Received: February 21, 2011
Last Updated: February 21, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Astellas Pharma Inc:
Mass Balance
ASP1941
Pharmacokinetics

ClinicalTrials.gov processed this record on June 13, 2013