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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease; Lung Disease

Treatments: Drug: Moxifloxacin; Drug: AZD3199; Other: Placebo comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01222442

D0570C00004

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

400 µg AZD3199 + moxifloxacin placebo

Treatment:

Drug: AZD3199

2

Experimental group

Description:

1200 µg AZD3199 + moxifloxacin placebo

Treatment:

Drug: AZD3199

3

Active Comparator group

Description:

AZD3199 placebo + moxifloxacin 400 mg

Treatment:

Drug: Moxifloxacin

4

Placebo Comparator group

Description:

AZD3199 placebo + moxifloxacin placebo

Treatment:

Other: Placebo comparator