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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723424
• Other study ID #: D1710C00021
• Secondary ID: EudraCt nr 2007-
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2008
• Last updated: November 30, 2010
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics

Intervention

Drug:
• AZD5672
50 mg, for 13 days
• Digoxin
0.5mg dose

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during study periods	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment periods	Yes