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

NCT ID: NCT00723424

Last Updated: 2010-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers Pharmacokinetics

Keywords

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AZD5672 digoxin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AZD5672 + Digoxin (single dose on day 12)

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

50 mg, for 13 days

Digoxin

Intervention Type DRUG

0.5mg dose

2

AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12)

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

50 mg, for 13 days

Digoxin

Intervention Type DRUG

0.5mg dose

Interventions

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AZD5672

50 mg, for 13 days

Intervention Type DRUG

Digoxin

0.5mg dose

Intervention Type DRUG

Other Intervention Names

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Lanoxin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Alderely Park

Principal Investigators

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Rod Hepburn

Role: STUDY_DIRECTOR

AstraZeneca R&D, Charnwood, UK

Rainard Fuhr

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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Research Site

Berlin, , Germany

Site Status

Countries

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Sweden Germany

Other Identifiers

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EudraCt nr 2007-007542-34

Identifier Type: -

Identifier Source: secondary_id

D1710C00021

Identifier Type: -

Identifier Source: org_study_id