To investigate the safety and pharmacokinetics of AZD9819

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel-group, 2-Part study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Acending Inhaled Doses of AZD9819 in Healthy Subjects.

• IRAS ID

  52786

• Contact name

  Leonard Siew

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2010-020505-32

• Research summary

  The drug being tested in this study is AZD9819. 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. This will be the first time AZD9819 has been tested in humans. The purpose of this research study is to determine the safety and tolerability of AZD9819 when given by inhalation. In addition, we will estimate how much AZD9819 enters the blood circulation and how the drug is cleared via the kidneys by collecting blood and urine samples from subjects during the study. We are also investigating whether the presence or absence of certain genes may affect the way the body handles AZD9819 (optionally). 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 a total of 100 healthy volunteers. .The information gained in this study will help the sponsor of this study to determine whether AZD9819 is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/51

• Date of REC Opinion

  8 Jul 2010

• REC opinion

  Favourable Opinion