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Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.

NCT ID: NCT00713791

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy Volunteers ZD4054

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

There are 5 variations of the ZD4054 (Zibotentan) 10mg tablet - A, B, C, D, and E. A minimum washout period of 1 week will occur between each treatment period.

Group Type EXPERIMENTAL

ZD4054

Intervention Type DRUG

Treatment period 1: 10mg oral solution

ZD4054

Intervention Type DRUG

Treatment period 2: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.

ZD4054

Intervention Type DRUG

Treatment period 3: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.

ZD4054

Intervention Type DRUG

Treatment period 4: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.

Interventions

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ZD4054

Treatment period 1: 10mg oral solution

Intervention Type DRUG

ZD4054

Treatment period 2: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.

Intervention Type DRUG

ZD4054

Treatment period 3: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.

Intervention Type DRUG

ZD4054

Treatment period 4: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice.

Intervention Type DRUG

Other Intervention Names

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Zibotentan Zibotentan Zibotentan Zibotentan

Eligibility Criteria

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Inclusion Criteria

* Normal resting 12-lead ECG with normal QTc interval (\<450 msec)
* Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening

Exclusion Criteria

* Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
* Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
* Judgement by the investigator, that the healthy volunteer should not participate in the study
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 Pharmaceuticals

Principal Investigators

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Sylvan Hurewitz

Role: PRINCIPAL_INVESTIGATOR

AZ Clinical Pharmacology Unit, Philadelphia, USA

Locations

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Research Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ZD4054IL0029

Identifier Type: -

Identifier Source: secondary_id

D4320C00029

Identifier Type: -

Identifier Source: org_study_id