Skip to main content
OpenTrials
Completed

NCT Number: NCT01222442

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchiolitis Bronchitis Chronic Disease Disease Attributes Emphysema Infections Lung Disease Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, UK, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD3199

Drug

Single dose, oral inhalation

moxifloxacin

Drug

Single dose, oral encapsulated tablet

Other names: Avelox®

Placebo Comparator

Other

Single dose, oral inhalation

Primary outcomes

  1. To investigate the effect of AZD3199 on the QT interval

    Time frame: Throughout the study

    QTcF or QTcI (algorithm based decision)

Secondary outcomes

  1. To investigate the effect of AZD3199 on additional electrocardiogram variables

    Time frame: Throughout the study

    • QTcF or QTcI dependent on variable confirmed as primary
    • Holter-Bin QT

  2. To assess the pharmacokinetics of single doses of AZD3199.

    Time frame: Throughout the study

    • AUC(0-24)
    • Cmax
    • tmax

  3. To evaluate the safety and tolerability of single doses of AZD3199.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single-centre, Randomised, Double-blind, Double-dummy, Placebo Controlled, 4-way Crossover Phase I Study to Investigate the Effect of 2 Single Doses (400 μg and 1200 µg) of Inhaled AZD3199 on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 18, 2010
Registry last updated
Feb 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.