Healthy Volunteers, Pharmacokinetics
Conditions
Keywords
AZD5672, digoxin
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).
Interventions
DRUGAZD5672
50 mg, for 13 days
DRUGDigoxin
0.5mg dose
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK variables | Frequent sampling occasions during study periods |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables (adverse events, blood pressure, pulse, safety lab) | During the whole treatment periods |
Countries
Germany
Outcome results
None listed