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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01222442

Enrollment

Registered

2010-10-18

Start date

2010-11-30

Completion date

2011-02-28

Last updated

2011-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Lung Disease

Keywords

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

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.

Interventions

DRUGAZD3199

Single dose, oral inhalation

DRUGMoxifloxacin

Single dose, oral encapsulated tablet

OTHERPlacebo comparator

Single dose, oral inhalation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026