Mass Balance Study of ASP1941

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01302132
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 1.2

Study Details

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
• Actual Enrollment: 6 participants
• Allocation: N/A
• 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 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of ASP1941 to evaluate metabolism and excretion [up to 216 hours]

Secondary Outcome Measures

1. Identification of metabolic profile of ASP1941 [up to 216 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1		Zuidlaren		Netherlands	9470 AE

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: Use Central Contact, Astellas Pharma Europe B.V.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01302132
• Other Study ID Numbers: 1941-CL-0055; 2008-000316-33
• First Posted: Feb 23, 2011
• Last Update Posted: Feb 23, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Mass Balance; ASP1941; Pharmacokinetics
• Additional relevant MeSH terms: Ipragliflozin

Study Results

No Results Posted as of Feb 23, 2011