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

September 27, 2010 updated by: AstraZeneca

A Phase I, Double-blind, Double-dummy, Placebo-controlled, Randomised, Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Volunteers Aged 18 to 45 Years.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ZD4054 + Moxifloxacin placebo
Drug: ZD4054
ZD4054 10mg Tablet
Other Names:
  • Zibotentan
Drug: Moxifloxacin placebo
1 capsule
Drug: ZD4054
30mg tablet
Drug: ZD4054
10mg tablet
Active Comparator: 2
ZD4054 placebo + Moxifloxacin
Drug: ZD4054
ZD4054 10mg Tablet
Other Names:
  • Zibotentan
Drug: ZD4054
30mg tablet
Drug: ZD4054
10mg tablet
Drug: Moxifloxacin
400 mg capsule
Other Names:
  • AVELOX
Drug: ZD4054 Placebo
3 tablets
Drug: ZD4054 Placebo
2 tablets
Experimental: 3
ZD4054 + ZD4054 placebo + Moxifloxacin placebo
Drug: ZD4054
ZD4054 10mg Tablet
Other Names:
  • Zibotentan
Drug: Moxifloxacin placebo
1 capsule
Drug: ZD4054
30mg tablet
Drug: ZD4054
10mg tablet
Drug: ZD4054 Placebo
3 tablets
Drug: ZD4054 Placebo
2 tablets
Placebo Comparator: 4
ZD4054 Placebo + Moxifloxacin placebo
Drug: ZD4054
ZD4054 10mg Tablet
Other Names:
  • Zibotentan
Drug: Moxifloxacin placebo
1 capsule
Drug: ZD4054
30mg tablet
Drug: ZD4054
10mg tablet
Drug: ZD4054 Placebo
3 tablets
Drug: ZD4054 Placebo
2 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
Time Frame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

Secondary Outcome Measures

Outcome Measure
Time Frame
assess the maximum of the mean changes in time-matched QT, QTcB (Bazett's correction), QTcF (Fridericia's correction) and QTcI (subject specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
Time Frame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo.
Time Frame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
further assess the safety and tolerability of ZD4054 (Zibotentan) by assessment of adverse events (AEs), laboratory variables and vital signs.
Time Frame: From time of Consent to Last Follow-up Visit
From time of Consent to Last Follow-up Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Raj Chetty, MD, Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 11, 2008

Study Record Updates

Last Update Posted (Estimate)

September 28, 2010

Last Update Submitted That Met QC Criteria

September 27, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4320C00017
  • ZD4054IL0017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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