Absolute Bioavailability Study With Ipragliflozin | NCT01611428

Studies
Absolute Bioavailability Study With Ipragliflozin

NCT01611428

Sponsor

Astellas Pharma Europe B.V.

Status

Completed

Last Update Posted

Jun 5, 2012Estimated

Enrollment

14Actual

Phase

Phase 1

Conditions

Bioavailability of Ipragliflozin
Healthy Subjects

Interventions

Ipragliflozin

Countries

United Kingdom

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
2010-023813-77	EudraCT Number

Status Module

Record Verification Date

May 2012

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

Jun 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

May 31, 2012

First Submission Date that Met QC Criteria

May 31, 2012

First Posted Date

Jun 5, 2012Estimated

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

May 31, 2012

Last Update Posted Date

Jun 5, 2012Estimated

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

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ipragliflozin - oral	Experimental	open label	Drug: Ipragliflozin
Ipragliflozin - i.v.	Experimental	open label	Drug: Ipragliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ipragliflozin	Drug	Oral and Intravenous (i.v.)	Ipragliflozin - i.v. Ipragliflozin - oral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of the absolute bioavailability after a single oral dose of ipragliflozin		6 days

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of pharmacokinetics of ipragliflozin and its metabolite after a single oral dose and after an i.v. administration of ipragliflozin	AUClast (Area under the plasma concentration-time curve up to the last quantifiable sample), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)	6 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

Any of the liver function tests above the upper limit of normal.
Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
A QTc interval of >430 ms (males) or > 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

Accepts Healthy Volunteers

Yes

Sex

All

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
Clinical Study Manager	Astellas Pharma Europe B.V.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Leeds		LS2 9LH	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C572941	ipragliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided