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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Lung Disease
• Interventions: Drug: AZD3199; Drug: Moxifloxacin; Other: Placebo comparator

• Registration Number: NCT01222442
• Lead Sponsor: AstraZeneca

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). 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Study Start: 2010-11
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-15
• Last Update Posted: 2011-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD3199	400 µg AZD3199 + moxifloxacin placebo
2	AZD3199	1200 µg AZD3199 + moxifloxacin placebo
3	Moxifloxacin	AZD3199 placebo + moxifloxacin 400 mg
4	Placebo comparator	AZD3199 placebo + moxifloxacin placebo

Primary Outcome Measures

Name	Time	Method
To investigate the effect of AZD3199 on the QT interval	Throughout the study	QTcF or QTcI (algorithm based decision)

Secondary Outcome Measures

Name	Time	Method
To investigate the effect of AZD3199 on additional electrocardiogram variables	Throughout the study	* QTcF or QTcI dependent on variable confirmed as primary; * Holter-Bin QT
To assess the pharmacokinetics of single doses of AZD3199.	Throughout the study	* AUC(0-24); * Cmax; * tmax
To evaluate the safety and tolerability of single doses of AZD3199.	Throughout the study	* Adverse events - type of events and number of subjects experiencing adverse events.; * Laboratory safety assessments, pulse, blood pressure and electrocardiogram interpretation - Summarised using descriptive stats. Judged regarding high/low values or changes from pre-dose.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, UK, United Kingdom