AZD8566 Food Effect/Microtracer Study

June 8, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose

Secondary Outcome Measures

Outcome 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
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.
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
Time Frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Intravenous pharmacokinetics
Time Frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Samples taken during visit 2, at up to 40 defined timepoints pre and post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Jo Collier, Dr,MB, ChB, Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimate)

March 20, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2009

Last Update Submitted That Met QC Criteria

June 8, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1320C00011
  • Pharmaceutical Profiles PL1168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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