An Interaction Study With Digoxin and AZD1305 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00712465

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: AZD1305 Drug: Digoxin	Phase I

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

Drug Information available for: Digoxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Phase I, Randomised, Open, Single-Centre, Three-Period Crossover Study to Evaluate the Effect of AZD1305 on the Pharmacokinetics of Digoxin After Repeated Oral Administration of AZD1305 and Digoxin to Young Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event, vital signs, ECG, physical examination and laboratory variables. [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	August 2008
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD1305 tablet	Drug: AZD1305 Extended Release tablet, repeated administration
2: Experimental AZD1305 tablet + digoxin	Drug: AZD1305 Extended Release tablet, repeated administration Drug: Digoxin Tablet, repeated administration
3: Active Comparator Digoxin	Drug: Digoxin Tablet, repeated administration

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712465

Locations

Sweden
Research Site
GÖTEBORG, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

Responsible Party:	AstraZeneca ( Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids )
Study ID Numbers:	D3190C00010, 2008-000577-37 (EudraCT No)
Study First Received:	July 8, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00712465
Health Authority:	Sweden: Medical Products Agency; United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Atrial fibrillation
interaction
pharmacokinetic

Study placed in the following topic categories:

Heart Diseases
Digoxin
Healthy
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors

Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009