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Food Effect Study of a Single Dose of ZD4054 (Zibotentan)

NCT ID: NCT00710047

Last Updated: 2010-11-15

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg single oral dose of ZD4054 (Zibotentan)

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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ZD4054 Zibotentan Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Fasting state

Group Type EXPERIMENTAL

ZD4054

Intervention Type DRUG

one single 10mg dose

2

after high-fat breakfast

Group Type EXPERIMENTAL

ZD4054

Intervention Type DRUG

one single 10mg dose

Interventions

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ZD4054

one single 10mg dose

Intervention Type DRUG

Other Intervention Names

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Zibotentan

Eligibility Criteria

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Inclusion Criteria

* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Able to consume standard FDA specified high-fat breakfast.

Exclusion Criteria

* Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
* Medical diagnosis of migraine with an attack during the 12 months prior to Screening
* Use of prescription medication within 2 weeks before dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Alderely Park

Principal Investigators

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Thomas Morris

Role: STUDY_DIRECTOR

AstraZeneca, Medical Science Director

David Wessels

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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Research Site

Harrow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ZD4054EudraCt 2008-002744-42

Identifier Type: -

Identifier Source: secondary_id

D4320C00028

Identifier Type: -

Identifier Source: org_study_id