Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval
Study identifier:D4320C00017
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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.
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ZD4054, ZD4054, ZD4054, ZD4054, Moxifloxacin, ZD4054 Placebo, ZD4054 Placebo, Moxifloxacin placebo, Moxifloxacin placebo, Moxifloxacin placebo, ZD4054 Placebo, ZD4054, ZD4054
Sex
Male
Actual enrollment
40
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Jun 2008
Primary Completion Date: -
Study Completion Date: 01 Nov 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Raj Chetty
Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG
