NCT01222442

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Lung Disease

Interventions

Type	Name	Description
DRUG	AZD3199	Single dose, oral inhalation
DRUG	Moxifloxacin	Single dose, oral encapsulated tablet
OTHER	Placebo comparator	Single dose, oral inhalation

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-10-18
• Last updated: 2011-02-16

Locations

1 site across 1 country: United Kingdom