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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers; Pharmacokinetics

Intervention: AZD5672 (Drug); Digoxin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Rod Hepburn, Study Director, Affiliation: AstraZeneca R&D, Charnwood, UK
Rainard Fuhr, Principal Investigator, Affiliation: PAREXEL International GmbH

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).

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: PK variables

Secondary outcome: Safety variables (adverse events, blood pressure, pulse, safety lab)

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Research Site, Berlin, Germany
Additional Information

Starting date: July 2008
Last updated: November 30, 2010

Page last updated: August 23, 2015

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