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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00866385

Enrollment

Registered

2009-03-20

Start date

2009-03-31

Completion date

2009-04-30

Last updated

2009-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer Study

Keywords

Healthy Volunteer, AZD8566, Food Effect, Microtracer

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.

Interventions

DRUGAZD8566

Single 6 mg oral solution dose

DRUGAZD8566 IV carbon labelled

Single 10 mcg intravenous carbon-14 microtracer dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026