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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00713336
First received: July 9, 2008
Last updated: September 27, 2010
Last verified: September 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2014