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

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ClinicalTrials.gov Identifier: NCT00713336
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : September 28, 2010
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: ZD4054 Drug: Moxifloxacin Drug: ZD4054 Placebo Drug: Moxifloxacin placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : June 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713336


Locations
United Kingdom
Research Site
Macclesfield, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Raj Chetty, MD Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG

Responsible Party: Dr Thomas Morris, Medical Science Director, AstraZeneca, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00713336     History of Changes
Other Study ID Numbers: D4320C00017
ZD4054IL0017
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010

Keywords provided by AstraZeneca:
ZD4054
Healthy Volunteers
QT interval

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
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
Nucleic Acid Synthesis Inhibitors