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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To investigate the effect of AZD3199 on the QT interval
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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.
Arms & Interventions
1
400 µg AZD3199 + moxifloxacin placebo
Intervention: AZD3199 (Drug)
2
1200 µg AZD3199 + moxifloxacin placebo
Intervention: AZD3199 (Drug)
3
AZD3199 placebo + moxifloxacin 400 mg
Intervention: Moxifloxacin (Drug)
4
AZD3199 placebo + moxifloxacin placebo
Intervention: Placebo comparator (Other)
Outcomes
Primary Outcomes
To investigate the effect of AZD3199 on the QT interval
Time Frame: Throughout the study
QTcF or QTcI (algorithm based decision)
Secondary Outcomes
- To investigate the effect of AZD3199 on additional electrocardiogram variables(Throughout the study)
- To assess the pharmacokinetics of single doses of AZD3199.(Throughout the study)
- To evaluate the safety and tolerability of single doses of AZD3199.(Throughout the study)