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Completed

NCT Number: NCT00723424

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

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

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Key information

Conditions

Healthy Volunteers Pharmacokinetics

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD5672

Drug

50 mg, for 13 days

Digoxin

Drug

0.5mg dose

Other names: Lanoxin

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during study periods

Secondary outcomes

  1. Safety variables (adverse events, blood pressure, pulse, safety lab)

    Time frame: During the whole treatment periods

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 28, 2008
Registry last updated
Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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