To investigate the effect of AZD1981 on the QT Interval

• Research type

  Research Study

• Full title

  A single-centre, double-blind, double-dummy, randomised, placebo controlled, four-period crossover study in healthy male volunteers, to assess the effect on QT/QTc interval of single oral doses of AZD1981 (200 mg and 2000 mg) using moxifloxacin (Avelox®) as a positive control. Protocol No: D9830C00011

• IRAS ID

  67143

• Contact name

  Leonard Siew

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2010-023338-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Atopic or allergic asthma is an increasingly common disease and is essentially caused by an allergic reaction of the immune system. Airways of the lungs become inflamed and narrow as a result of a reaction to things like allergens (proteins that are responsible for causing an allergic reaction e.g. pollen, house dust mite, cat/dog fur). The airways become blocked, causing shortness of breath, cough and wheezing. AZD1981 is a new drug being developed for the treatment of asthma and hopefully it will reduce inflammation in the lung and thereby reducing shortness of breath, cough and wheezing seen in asthma.This is not the first time that AZD1981 will be administered to humans in clinical trials.The purpose of this research study is to evaluate the effect of AZD1981 on the electrical activity of the heart. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which is well known to affect the electrical activity of the heart, but this effect is known to be at levels that are safe at the dose used in this study. We will also compare the effects of AZD1981 with a ??dummy drug? (placebo). We will also be evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters your blood circulation by collecting blood from you during the study. Approximately 44 healthy volunteers will take part.AZD1981 is being developed by AstraZeneca (the Sponsor, a pharmaceutical company) and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy??s Hospital (hereafter referred to as Quintiles).The information gained in this study will help the sponsor of this study to determine whether AZD1981 is suitable for further studies in humans.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/31

• Date of REC Opinion

  13 Dec 2010

• REC opinion

  Further Information Favourable Opinion