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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Pharmacokinetics

Treatments: Drug: AZD5672; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00723424

EudraCt nr 2007-007542-34

D1710C00021

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

AZD5672 + Digoxin (single dose on day 12)

Treatment:

Drug: Digoxin

Drug: AZD5672

2

Experimental group

Description:

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

Treatment:

Drug: Digoxin

Drug: AZD5672