Status:
COMPLETED
To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Lung Disease
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxiflo...
Eligibility Criteria
Inclusion
- Healthy male subjects aged 18 to 45 years (inclusive)
- Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg.
- Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.
- Be able to inhale from the Turbuhaler inhaler according to given instructions.
Exclusion
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings at screening examination
- History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalaemia, or family history of long QT syndrome).
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01222442
Start Date
November 1 2010
End Date
February 1 2011
Last Update
February 16 2011
Active Locations (1)
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1
Research Site
London, UK, United Kingdom