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Completed

NCT Number: NCT00866385

AZD8566 Food Effect/Microtracer Study

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.

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8566

Drug

Single 6 mg oral solution dose

AZD8566 IV carbon labelled

Drug

Single 10 mcg intravenous carbon-14 microtracer dose

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 20, 2009
Registry last updated
Jun 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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