To evaluate the effect of AZD3199 on the electrical activity in the heart
Study identifier:D0570C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A single-centre, randomised, double-blind, double-dummy, placebo controlled, 4-way crossover Phase I study to investigate the effect of 2 single doses (400 μg and 1200 µg) of inhaled AZD3199 on QT/QTc interval, compared to placebo, using moxifloxacin (Avelox®) as a positive control, in healthy male volunteers
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3199, Moxifloxacin
Sex
Male
Actual Enrollment
40
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Nov 2010
Primary Completion Date: 01 Feb 2011
Study Completion Date: 01 Feb 2011
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: 1 400 µg AZD3199 + moxifloxacin placebo | Drug: AZD3199 Single dose, oral inhalation |
| Experimental: 2 1200 µg AZD3199 + moxifloxacin placebo | Drug: AZD3199 Single dose, oral inhalation |
| Active Comparator: 3 AZD3199 placebo + moxifloxacin 400 mg | Drug: Moxifloxacin Single dose, oral encapsulated tablet Other Name: Avelox® |
| Placebo Comparator: 4 AZD3199 placebo + moxifloxacin placebo | Other: Placebo comparator Single dose, oral inhalation |
Contacts
Investigators
Principal Investigator
Carin Jorup
AstraZeneca R&D, Lund, Sweden
