ClinicalTrials.gov
ClinicalTrials.gov Menu

An Interaction Study With Digoxin and AZD1305

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00712465
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: AZD1305 Drug: Digoxin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: During all dosing visits ]

Secondary Outcome Measures :
  1. Adverse event, vital signs, ECG, physical examination and laboratory variables. [ Time Frame: During the study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Atrial fibrillation
interaction
pharmacokinetic

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs