To investigate the effects of AZD1981 on the QT interval
Study identifier:D9830C00011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-023338-22
CTIS identifier:N/A
Study Complete
Official Title
A single-centre, double-blind, double-dummy, randomised, placebo controlled, four-period crossover study in healthy male volunteers, to assess the effect on QT/QTc interval of single oral doses of AZD1981 (200 mg and 2000 mg) using moxifloxacin (Avelox®) as a positive control
Medical condition
asthma
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1981, 2000mg, AZD1981, 200mg, Moxifloxacin, 400mg, Placebo
Sex
Male
Actual Enrollment
44
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jan 2011
Primary Completion Date: 01 Apr 2011
Study Completion Date: 01 Apr 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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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: AZD1981, 2000mg Single oral dose, tablets |
| Experimental: 2 | Drug: AZD1981, 200mg Single oral dose, tablets |
| Experimental: 3 | Drug: Moxifloxacin, 400mg Single oral dose, capsule |
| Placebo Comparator: 4 | Drug: Placebo Single oral dose, tablets |
