Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers; Pharmacokinetics
Intervention: AZD5672 (Drug); Digoxin (Drug)
Phase: Phase 1
Status: Recruiting
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
Overall contact:
Nils Piwon, Phone: +49-30-30685-0, Email: nils.piwon@parexel.com
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: Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
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
Nils Piwon, Phone: +49-30-30685-0, Email: nils.piwon@parexel.com
Research Site, Berlin, Germany; Recruiting
Additional Information
Starting date: July 2008
Ending date: January 2009
Last updated: July 29, 2008
|
