Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin
- Registration Number
- NCT00723424
- Lead Sponsor
- AstraZeneca
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD5672 AZD5672 + Digoxin (single dose on day 12) 1 Digoxin AZD5672 + Digoxin (single dose on day 12) 2 AZD5672 AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12) 2 Digoxin AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12)
- Primary Outcome Measures
Name Time Method PK variables Frequent sampling occasions during study periods
- Secondary Outcome Measures
Name Time Method Safety variables (adverse events, blood pressure, pulse, safety lab) During the whole treatment periods
Trial Locations
- Locations (1)
Research Site
🇩🇪Berlin, Germany