AZD8566 Food Effect/Microtracer Study
An Open, Randomised, Phase I, 2-Period Crossover Trial to Investigate the Absolute Bioavailability and the Effect of Food on the Oral Bioavailability of AZD8566 in Healthy Volunteers
2 other identifiers
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 19, 2009
CompletedFirst Posted
Study publicly available on registry
March 20, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJune 9, 2009
June 1, 2009
Same day
March 19, 2009
June 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Interventions
Single 6 mg oral solution dose
Single 10 mcg intravenous carbon-14 microtracer dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Nottingham, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Jo Collier, Dr,MB, ChB
Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 19, 2009
First Posted
March 20, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2009
Study Completion
April 1, 2009
Last Updated
June 9, 2009
Record last verified: 2009-06