Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00723424

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 I

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

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

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 February 09, 2012