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Clinical Trials/NCT01302132
NCT01302132
Completed
Phase 1

An Open Label Study to Evaluate the Pharmacokinetics of ASP1941 After a Single Oral Dose of 14C-labeled ASP1941 in Healthy Male Subjects

Astellas Pharma Inc0 sites6 target enrollmentMay 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy Subjects
Sponsor
Astellas Pharma Inc
Enrollment
6
Primary Endpoint
Pharmacokinetics of ASP1941 to evaluate metabolism and excretion
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
October 2008
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Pharmacokinetics of ASP1941 to evaluate metabolism and excretion

Time Frame: up to 216 hours

Secondary Outcomes

  • Identification of metabolic profile of ASP1941(up to 216 hours)

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