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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Pharmacokinetics
• Intervention / Treatment: Drug: AZD5672; Drug: Digoxin

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; AZD5672 + Digoxin (single dose on day 12)	Drug: AZD5672; 50 mg, for 13 days; Drug: Digoxin; 0.5mg dose; Other Names: 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 Names: Lanoxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK variables	Frequent sampling occasions during study periods

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety variables (adverse events, blood pressure, pulse, safety lab)	During the whole treatment periods

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: July 24, 2008
• First Submitted That Met QC Criteria: July 24, 2008
• First Posted (Estimate): July 28, 2008

Study Record Updates

• Last Update Posted (Estimate): December 2, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: AZD5672; digoxin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protective Agents; Cardiotonic Agents; CCR5 Receptor Antagonists; Digoxin; N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
• Other Study ID Numbers: D1710C00021; EudraCt nr 2007-007542-34