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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Lung Disease

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

AZD3199

Moxifloxacin

Placebo comparator

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring Respiratory disease, Bronchiolitis, Emphysema, Lung disease causing persistent narrowing of the airways

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts 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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

400 µg AZD3199 + moxifloxacin placebo

1200 µg AZD3199 + moxifloxacin placebo

AZD3199 placebo + moxifloxacin 400 mg

AZD3199 placebo + moxifloxacin placebo

Outcomes

Primary Outcome Measures

To investigate the effect of AZD3199 on the QT interval

QTcF or QTcI (algorithm based decision)

Secondary Outcome Measures

To investigate the effect of AZD3199 on additional electrocardiogram variables

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

To assess the pharmacokinetics of single doses of AZD3199.

AUC(0-24) Cmax tmax

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

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.

Full Information

NCT ID

NCT01222442

First Posted

October 12, 2010

Last Updated

February 15, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01222442

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, Lung Disease

Keywords

Respiratory disease, Bronchiolitis, Emphysema, Lung disease causing persistent narrowing of the airways

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

400 µg AZD3199 + moxifloxacin placebo

Arm Title

Arm Type

Experimental

Arm Description

1200 µg AZD3199 + moxifloxacin placebo

Arm Title

Arm Type

Active Comparator

Arm Description

AZD3199 placebo + moxifloxacin 400 mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

AZD3199 placebo + moxifloxacin placebo

Intervention Type

Drug

Intervention Name(s)

AZD3199

Intervention Description

Single dose, oral inhalation

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Other Intervention Name(s)

Avelox®

Intervention Description

Single dose, oral encapsulated tablet

Intervention Type

Other

Intervention Name(s)

Placebo comparator

Intervention Description

Single dose, oral inhalation

Primary Outcome Measure Information:

Title

To investigate the effect of AZD3199 on the QT interval

Description

QTcF or QTcI (algorithm based decision)

Time Frame

Throughout the study

Secondary Outcome Measure Information:

Title

To investigate the effect of AZD3199 on additional electrocardiogram variables

Description

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

Time Frame

Throughout the study

Title

To assess the pharmacokinetics of single doses of AZD3199.

Description

AUC(0-24) Cmax tmax

Time Frame

Throughout the study

Title

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

Description

Time Frame

Throughout the study

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carin Jorup, MD

Organizational Affiliation

AstraZeneca R&D, Lund, Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Leonard Siew, MB CHB

Organizational Affiliation

Quintiles Drug Research Unit at Guy's Hospital, London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

London

State/Province

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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