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Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval

NCT ID: NCT00713336

Last Updated: 2010-09-28

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-11-30

Brief Summary

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This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

ZD4054 + Moxifloxacin placebo

Group Type EXPERIMENTAL

ZD4054

Intervention Type DRUG

ZD4054 10mg Tablet

Moxifloxacin placebo

Intervention Type DRUG

1 capsule

ZD4054

Intervention Type DRUG

30mg tablet

2

ZD4054 placebo + Moxifloxacin

Group Type ACTIVE_COMPARATOR

ZD4054

Intervention Type DRUG

ZD4054 10mg Tablet

Moxifloxacin

Intervention Type DRUG

400 mg capsule

ZD4054 Placebo

Intervention Type DRUG

3 tablets

3

ZD4054 + ZD4054 placebo + Moxifloxacin placebo

Group Type EXPERIMENTAL

ZD4054

Intervention Type DRUG

ZD4054 10mg Tablet

Moxifloxacin placebo

Intervention Type DRUG

1 capsule

ZD4054 Placebo

Intervention Type DRUG

2 tablets

ZD4054

Intervention Type DRUG

10mg tablet

4

ZD4054 Placebo + Moxifloxacin placebo

Group Type PLACEBO_COMPARATOR

ZD4054

Intervention Type DRUG

ZD4054 10mg Tablet

ZD4054 Placebo

Intervention Type DRUG

3 tablets

Moxifloxacin placebo

Intervention Type DRUG

1 capsule

Interventions

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ZD4054

ZD4054 10mg Tablet

Intervention Type DRUG

Moxifloxacin

400 mg capsule

Intervention Type DRUG

ZD4054 Placebo

3 tablets

Intervention Type DRUG

Moxifloxacin placebo

1 capsule

Intervention Type DRUG

ZD4054 Placebo

2 tablets

Intervention Type DRUG

ZD4054

30mg tablet

Intervention Type DRUG

ZD4054

10mg tablet

Intervention Type DRUG

Other Intervention Names

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Zibotentan AVELOX

Eligibility Criteria

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Inclusion Criteria

* Non Smoker
* 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

45 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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Raj Chetty, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG

Locations

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Research Site

Macclesfield, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ZD4054IL0017

Identifier Type: -

Identifier Source: secondary_id

D4320C00017

Identifier Type: -

Identifier Source: org_study_id