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, Moxifloxacin, ZD4054 Placebo, Moxifloxacin placebo
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
