Drug-drug Interaction Study With ASP1941 and Glimepiride | NCT01302158

Studies
Drug-drug Interaction Study With ASP1941 and Glimepiride

NCT01302158

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Feb 23, 2011Estimated

Enrollment

52Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

ASP1941
Glimepiride

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
2009-013172-50	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

Dec 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

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

A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

Detailed Description

Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.

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

52Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	oral
Glimepiride	Drug	oral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride		14 days

Secondary Outcomes

Measure	Description	Time Frame
Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI between 18.5 and 30 kg/m2, inclusive

Exclusion Criteria:

Any of the liver function tests above the upper limit of normal
Pulse <40 or >90 bpm; Systolic Blood Pressure >140 mmHg; Diastolic Blood Pressure > 90 mmHg

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
Use Central Contact	Astellas Pharma Europe B.V.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Groningen		9470 AE	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
C572941	ipragliflozin
C057619	glimepiride

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided