Drug Interaction Study - Effect of AZD5672 on the Pharmac... | NCT00723424

Studies
Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin

NCT00723424

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 2, 2010Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

Healthy Volunteers
Pharmacokinetics

Interventions

AZD5672
Digoxin

Countries

Germany

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
EudraCt nr 2007-007542-34

Status Module

Record Verification Date

Nov 2010

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

Jul 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 24, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 28, 2008Estimated

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

Nov 30, 2010

Last Update Posted Date

Dec 2, 2010Estimated

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

The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the pharmacokinetics of digoxin (single dose administration).

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

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	AZD5672 + Digoxin (single dose on day 12)	Drug: AZD5672 Drug: Digoxin
2	Experimental	AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12)	Drug: AZD5672 Drug: Digoxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD5672	Drug	50 mg, for 13 days	1 2
Digoxin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK variables		Frequent sampling occasions during study periods

Secondary Outcomes

Measure	Description	Time Frame
Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment periods

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of signed written informed consent.
Females should not be of childbearing potential
Clinically normal physical and laboratory findings as judged by the investigator, including negative drug test and negative tests of Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV.

Exclusion Criteria:

Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
Known allergy to digoxin or previous complications to digoxin therapy.
Participation in any clinical study involving an investigational product in the 3 months prior to enrolment.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rod Hepburn	AstraZeneca R&D, Charnwood, UK	Study Director
Rainard Fuhr	Parexel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Berlin			Germany

Intervention Browse Module

MeSH Terms

ID	Term
C553747	N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
D004077	Digoxin

Ancestor Terms

ID	Term
D004071	Digitalis Glycosides
D002298	Cardenolides
D002301	Cardiac Glycosides
D002297	Cardanolides

Browse Leaves

Not provided

Browse Branches

Not provided