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

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ClinicalTrials.gov Identifier: NCT00723424
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : December 2, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Pharmacokinetics Drug: AZD5672 Drug: Digoxin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. PK variables [ Time Frame: Frequent sampling occasions during study periods ]

Secondary Outcome Measures :
  1. Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment periods ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

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): 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

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
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
AZD5672
digoxin

Additional relevant MeSH terms:
Digoxin
N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
CCR5 Receptor Antagonists
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents