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An Interaction Study With Digoxin and AZD1305

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00712465
First received: July 8, 2008
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  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 1

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:

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 May 19, 2013