Mass Balance Study of ASP1941 | NCT01302132

Studies
Mass Balance Study of ASP1941

NCT01302132

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Feb 23, 2011Estimated

Enrollment

6Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

ASP1941

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-000316-33	EudraCT Number

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Feb 21, 2011

First Submission Date that Met QC Criteria

Feb 21, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2011

Last Update Posted Date

Feb 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	Oral solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of ASP1941 to evaluate metabolism and excretion		up to 216 hours

Secondary Outcomes

Measure	Description	Time Frame
Identification of metabolic profile of ASP1941		up to 216 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Europe B.V.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Zuidlaren		9470 AE	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
C572941	ipragliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided