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

Condition(s) targeted: Healthy

Intervention: ZD4054 (Drug); Moxifloxacin (Drug); ZD4054 Placebo (Drug); Moxifloxacin placebo (Drug); ZD4054 Placebo (Drug); ZD4054 (Drug); ZD4054 (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Raj Chetty, MD, Principal Investigator, Affiliation: Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG

Overall contact:
Raj Chetty, Phone: +44 (0) 1625 518078

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

Official title: A Phase I, Double-Blind, Double-Dummy, Placebo-Controlled, Randomised, Four-Period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (10mg and 30mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Volunteers Aged 18 to 45 Years.

Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety Study

Primary outcome: to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 administration (10mg and 30mg) compared to placebo

Secondary outcome:

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 administration (10mg and 30mg) compared to placebo

assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo.

further assess the safety and tolerability of ZD4054 by assessment of adverse events (AEs), laboratory variables and vital signs.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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

Raj Chetty, Phone: +44 (0) 1625 518078

Research Site, Macclesfield, United Kingdom; Recruiting

Starting date: June 2008
Ending date: January 2009
Last updated: July 10, 2008