To investigate the effect of AZD3199 on the QT Interval

• Research type

  Research Study

• Full 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

• IRAS ID

  61535

• Contact name

  Leonard Siew

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2010-020139-37

• Research summary

  The drug being tested in this study is AZD3199. It is being developed for the treatment of chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worse over time. There is an urgent medical need for therapies that could slow disease progression by targeting the underlying Mechanisms associated with the changes in the lungs in patients with COPD. The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart, in particular when the heart muscle is relaxed during a heartbeat cycle. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin) which is well known to prolong the time the heart muscle is relaxed during a heartbeat cycle. We will also be evaluating the safety and tolerability of AZD3199 and how much AZD3199 enters your blood circulation by collecting blood from you during the study. The study will take place at Quintiles Drug research Unit at Guy's Hospital, Quintiles Ltd. The study involves several visits to the research unit, with a pre-study screening visit and a post-study follow-up visit. The study is expected to involve approximately 40 healthy volunteers. The information gained in this study will help the sponsor of this study to determine whether AZD3199 is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/72

• Date of REC Opinion

  28 Oct 2010

• REC opinion

  Further Information Favourable Opinion