An Interaction Study With Digoxin and AZD1305 - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

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

MedlinePlus related topics: Atrial Fibrillation Drug Reactions

Drug Information available for: Digoxin

U.S. FDA Resources

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:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

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

No publications provided

Responsible Party:	Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00712465 History of Changes
Other Study ID Numbers:	D3190C00010, 2008-000577-37 (EudraCT No)
Study First Received:	July 8, 2008
Last Updated:	December 2, 2010
Health Authority:	Sweden: Medical Products Agency; United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Atrial fibrillation
interaction
pharmacokinetic

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Digoxin
Cardiotonic Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012