An Interaction Study With Digoxin and AZD1305 | NCT00712465

Studies
An Interaction Study With Digoxin and AZD1305

NCT00712465

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 3, 2010Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Atrial Fibrillation

Interventions

AZD1305
Digoxin

Countries

Sweden

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
2008-000577-37 (EudraCT No)

Status Module

Record Verification Date

Dec 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

Aug 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Jul 8, 2008

First Submission Date that Met QC Criteria

Jul 9, 2008

First Posted Date

Jul 10, 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

Dec 2, 2010

Last Update Posted Date

Dec 3, 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 primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how AZD1305 and digoxin administered alone and in combination affect the body.

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	AZD1305 tablet	Drug: AZD1305
2	Experimental	AZD1305 tablet + digoxin	Drug: AZD1305 Drug: Digoxin
3	Active Comparator	Digoxin	Drug: Digoxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD1305	Drug	Extended Release tablet, repeated administration	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic variables		During all dosing visits

Secondary Outcomes

Measure	Description	Time Frame
Adverse event, vital signs, ECG, physical examination and laboratory variables.		During the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

Potassium outside normal reference values
ECG findings outside normal range

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helen Lunde, MD	AstraZeneca R&D, Mölndal, Sweden	Study Director
Marianne Hartford, MD, PhD	AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Gothenburg			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C550721	tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate
D004077	Digoxin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided