A study to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart
Study identifier:D1710C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
Medical condition
Rheumatoid Arthritis
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5672, Moxifloxacin, placebo
Sex
Male
Actual Enrollment
64
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Apr 2009
Primary Completion Date: -
Study Completion Date: 01 Jul 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Quintiles Limited
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: A 600mg AZD5672 + Moxifloxacin placebo | Drug: AZD5672 12 x 50mg tablet, oral, single dose Drug: placebo 1 x matched to Moxifloxacin capsule |
| Experimental: B 100mg AZD5672 + Moxifloxacin placebo | Drug: AZD5672 3 x 50mg tablet, oral. single dose Drug: placebo 9 x matched to AZD5672 50mg tablet Drug: placebo 1 x matched to Moxifloxacin capsule |
| Active Comparator: C AZD5672 placebo + Moxifloxacin 400mg | Drug: Moxifloxacin 1 x 400mg capsule, oral, single dose Other Name: Avelox Drug: placebo 12 x matched to AZD5672 50 mg tablet |
| Placebo Comparator: D AZD5672 placebo + Moxifloxacin placebo | Drug: placebo 12 x matched to AZD5672 50 mg tablet Drug: placebo 1 x matched to Moxifloxacin capsule |
Contacts
Investigators
Principal Investigator
Mark Layton
AstraZeneca R&D, Alderley Park, UK
