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Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00723424
First received: July 24, 2008
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the pharmacokinetics of digoxin (single dose administration).


Condition Intervention Phase
Healthy Volunteers
Pharmacokinetics
 Drug: AZD5672
Drug: Digoxin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label Study to Assess the Effect of AZD5672 at Steady State on the Pharmacokinetics of Digoxin Following Single Dose Administration in Healthy 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:
  • PK variables [ Time Frame: Frequent sampling occasions during study periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment periods ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD5672 + Digoxin (single dose on day 12)
 Drug: AZD5672
50 mg, for 13 days
Drug: Digoxin
0.5mg dose
Other Name: Lanoxin
Experimental: 2
AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12)
 Drug: AZD5672
50 mg, for 13 days
Drug: Digoxin
0.5mg dose
Other Name: Lanoxin

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed written informed consent.
  • Females should not be of childbearing potential
  • Clinically normal physical and laboratory findings as judged by the investigator, including negative drug test and negative tests of Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV.

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
  • Known allergy to digoxin or previous complications to digoxin therapy.
  • Participation in any clinical study involving an investigational product in the 3 months prior to enrolment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723424

Locations
Germany
Research Site
Berlin, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rod Hepburn AstraZeneca R&D, Charnwood, UK
Principal Investigator: Rainard Fuhr PAREXEL International GmbH
  More Information

No publications provided

Responsible Party: Mark Layton, MD, PhD, Medical Science Director, AstraZeneca R&D Alderely Park
ClinicalTrials.gov Identifier: NCT00723424     History of Changes
Other Study ID Numbers: D1710C00021, EudraCt nr 2007-007542-34
Study First Received: July 24, 2008
Last Updated: November 30, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
AZD5672
digoxin

Additional relevant MeSH terms:
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 23, 2013