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

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: ZD4054 Drug: Moxifloxacin Drug: ZD4054 Placebo Drug: Moxifloxacin placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
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 (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.

Resource links provided by NLM:

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	June 2008
Study Completion Date:	November 2008

Arms	Assigned Interventions
Experimental: 1 ZD4054 + Moxifloxacin placebo	Drug: ZD4054 ZD4054 10mg Tablet Other Name: Zibotentan Drug: Moxifloxacin placebo 1 capsule Drug: ZD4054 30mg tablet
Active Comparator: 2 ZD4054 placebo + Moxifloxacin	Drug: ZD4054 ZD4054 10mg Tablet Other Name: Zibotentan Drug: Moxifloxacin 400 mg capsule Other Name: AVELOX Drug: ZD4054 Placebo 3 tablets
Experimental: 3 ZD4054 + ZD4054 placebo + Moxifloxacin placebo	Drug: ZD4054 ZD4054 10mg Tablet Other Name: Zibotentan Drug: Moxifloxacin placebo 1 capsule Drug: ZD4054 Placebo 2 tablets Drug: ZD4054 10mg tablet
Placebo Comparator: 4 ZD4054 Placebo + Moxifloxacin placebo	Drug: ZD4054 ZD4054 10mg Tablet Other Name: Zibotentan Drug: ZD4054 Placebo 3 tablets Drug: Moxifloxacin placebo 1 capsule

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713336

Locations

United Kingdom
Research Site
Macclesfield, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Raj Chetty, MD

Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG

More Information

No publications provided

Responsible Party:	Dr Thomas Morris, Medical Science Director, AstraZeneca, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00713336 History of Changes
Other Study ID Numbers:	D4320C00017, ZD4054IL0017
Study First Received:	July 9, 2008
Last Updated:	September 27, 2010
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

ZD4054
Healthy Volunteers
QT interval

Additional relevant MeSH terms:

Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined

Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013