Healthy Volunteers
Conditions
Keywords
AZD5672
Brief summary
The purpose of the study is to estimate the absolute bioavailability at steady state of 2 doses of AZD5672 (50 mg and 150 mg administered orally once daily)
Interventions
DRUGAZD5672
single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of informed consent prior to any study specific procedures. * Females should not be of childbearing potential * Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results
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 * Unsuitable venous access for intravenous studies * Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).
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
United Kingdom
Outcome results
None listed