Mass Balance Study of ASP1941

Phase 1

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT01302132
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2011-02
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-21
• Last Update Submitted: 2011-02-21
• Study First Posted: 2011-02-23
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of ASP1941 to evaluate metabolism and excretion	up to 216 hours

Secondary Outcome Measures

Name	Time	Method
Identification of metabolic profile of ASP1941	up to 216 hours