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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ZD4054 Placebo; Drug: ZD4054; Drug: Moxifloxacin placebo; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713336

D4320C00017

ZD4054IL0017

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

ZD4054 + Moxifloxacin placebo

Treatment:

Drug: ZD4054

Drug: Moxifloxacin placebo

Drug: ZD4054

Drug: ZD4054

2

Active Comparator group

Description:

ZD4054 placebo + Moxifloxacin

Treatment:

Drug: ZD4054

Drug: ZD4054 Placebo

Drug: Moxifloxacin

Drug: ZD4054 Placebo

Drug: ZD4054

Drug: ZD4054

3

Experimental group

Description:

ZD4054 + ZD4054 placebo + Moxifloxacin placebo

Treatment:

Drug: ZD4054

Drug: ZD4054 Placebo

Drug: Moxifloxacin placebo

Drug: ZD4054 Placebo

Drug: ZD4054

Drug: ZD4054

4

Placebo Comparator group

Description:

ZD4054 Placebo + Moxifloxacin placebo

Treatment:

Drug: ZD4054

Drug: ZD4054 Placebo

Drug: Moxifloxacin placebo

Drug: ZD4054 Placebo

Drug: ZD4054

Drug: ZD4054