AZD8566 Food Effect/Microtracer Study

NCT ID: NCT00866385

Last Updated: 2009-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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AZD8566

Single 6 mg oral solution dose

Intervention Type DRUG

AZD8566 IV carbon labelled

Single 10 mcg intravenous carbon-14 microtracer dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Jo Collier, Dr,MB, ChB

Role: PRINCIPAL_INVESTIGATOR

Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS

Locations

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Research Site

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Pharmaceutical Profiles PL1168

Identifier Type: -

Identifier Source: secondary_id

D1320C00011

Identifier Type: -

Identifier Source: org_study_id

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