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CompletedNCT00866385Updated Jun 9, 2009

AZD8566 Food Effect/Microtracer Study

A Phase 1 interventional study of AZD8566 and AZD8566 IV carbon labelled in Healthy Volunteer Study, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-09.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer Study

Keywords

  • Healthy Volunteer
  • AZD8566
  • Food Effect
  • Microtracer
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,498 studies on the registry; 269 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food

    Time frame: Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose

Secondary outcomes

  1. 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

    Time frame: 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.

  2. Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose

    Time frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose

  3. Intravenous pharmacokinetics

    Time frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose

07

Study locations

1 site
  • Research Site
    Nottingham, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2009, a primary completion of Mar 2009 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2009
First posted
Mar 20, 2009
Start
Mar 2009
Primary completionActual
Mar 2009
CompletionActual
Apr 2009
Last update
Jun 9, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00866385
Lead sponsor
AstraZeneca
First posted
Mar 20, 2009
Start date
Mar 2009
Primary completion
Mar 2009
Completion
Apr 2009
Last update
Jun 9, 2009

Study contacts

Jo Collier, Dr,MB, ChB
principal investigator · Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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