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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01222442

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

13.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Lung Disease	Drug: AZD3199 Drug: Moxifloxacin Other: Placebo comparator	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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 Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 400 µg AZD3199 + moxifloxacin placebo	Drug: AZD3199 Single dose, oral inhalation
Experimental: 2 1200 µg AZD3199 + moxifloxacin placebo	Drug: AZD3199 Single dose, oral inhalation
Active Comparator: 3 AZD3199 placebo + moxifloxacin 400 mg	Drug: Moxifloxacin Single dose, oral encapsulated tablet Other Names: Avelox®
Placebo Comparator: 4 AZD3199 placebo + moxifloxacin placebo	Other: Placebo comparator Single dose, oral inhalation

Outcome Measures

Primary Outcome Measures

To investigate the effect of AZD3199 on the QT interval [Throughout the study]
QTcF or QTcI (algorithm based decision)

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	London	UK	United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Carin Jorup, MD, AstraZeneca R&D, Lund, Sweden
Principal Investigator: Leonard Siew, MB CHB, Quintiles Drug Research Unit at Guy's Hospital, London