AZD8566 Food Effect/Microtracer Study
Phase 1
Completed
- Conditions
- Healthy Volunteer Study
- Registration Number
- NCT00866385
- Lead Sponsor
- AstraZeneca
- Brief Summary
A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Provision of written informed consent
- Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- Females who are permanently or surgically sterile or post-menopausal and males
Exclusion Criteria
- History of any convulsions or seizures
- History of infection or risk of infection due to recent surgery or trauma
- History or presence of conditions know to interfere with the absorption, distribution, metabolism and excretion of the study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose
- Secondary Outcome Measures
Name Time Method Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events. Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose Samples taken during visit 2, at up to 40 defined timepoints pre and post dose Intravenous pharmacokinetics Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Trial Locations
- Locations (1)
Research Site
🇬🇧Nottingham, United Kingdom