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Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.

NCT ID: NCT00844103

Last Updated: 2009-04-30

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.

Detailed Description

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Conditions

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Pharmacokinetics

Keywords

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Volunteer Safety Tolerability AZD8566

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD8566

Intervention Type DRUG

10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10ml oral solution administered once a day over 10 days.

Interventions

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AZD8566

10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee

Intervention Type DRUG

Placebo

10ml oral solution administered once a day over 10 days.

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 postmenopausal and males.

Exclusion Criteria

* Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
* History of any convulsions or seizures
* History of infection or at risk of infection due to recent surgery or trauma
* History or presence of conditions known 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 Pharmaceuticals

Principal Investigators

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Emeline Ramos, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Unit

Locations

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Research Site

Macclesfield, Cheshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D1320C00002

Identifier Type: -

Identifier Source: org_study_id