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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222442
• Other study ID #: D0570C00004
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2010
• Last updated: February 15, 2011
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD3199
Single dose, oral inhalation
• Moxifloxacin
Single dose, oral encapsulated tablet

Other:
• Placebo comparator
Single dose, oral inhalation

Locations

Country	Name	City	State
United Kingdom	Research Site	London	UK

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the effect of AZD3199 on the QT interval	QTcF or QTcI (algorithm based decision)	Throughout the study	Yes
Secondary	To investigate the effect of AZD3199 on additional electrocardiogram variables	QTcF or QTcI dependent on variable confirmed as primary; Holter-Bin QT	Throughout the study	Yes
Secondary	To assess the pharmacokinetics of single doses of AZD3199.	AUC(0-24); Cmax; tmax	Throughout the study	No
Secondary	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.	Throughout the study	Yes