To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

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). Moxifloxacin effects on the electrical activity of the heart are well known. Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will also be assessed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: AZD-3199; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.