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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00713336

Enrollment

Registered

2008-07-11

Start date

2008-06-30

Completion date

2008-11-30

Last updated

2010-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ZD4054, Healthy Volunteers, QT interval

Brief summary

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

Interventions

DRUGZD4054

ZD4054 10mg Tablet

DRUGMoxifloxacin

400 mg capsule

DRUGZD4054 Placebo

3 tablets

DRUGMoxifloxacin placebo

1 capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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	Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

Secondary

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	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.	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.	From time of Consent to Last Follow-up Visit

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026