To investigate the safety and pharmacokinetics of AZD6553

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Double-Blind, Placebo-Controlled, 3-Part study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD6553 in Healthy Volunteers (Parts A and B) and Patients (Part C) with Chronic Obstructive Pulmonary Disease

• IRAS ID

  38246

• Contact name

  Leonard Siew

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2009-016931-36

• Research summary

  The drug being tested in this study is AZD6553. 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 AZD6553 has been tested in humans. The purpose of this research study is to determine the safety and tolerability of AZD6553. In addition, we will estimate how much AZD6553 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 food affects the absorption of the drug, what the drug is broken down into when given orally (by mouth), and (optionally) the presence or absence of certain genes that may affect the way the body handles AZD6553. 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 66 healthy volunteers and 18 patients with moderate to severe COPD. The information gained in this study will help the sponsor of this study to determine whether AZD6553 is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/99

• Date of REC Opinion

  5 Feb 2010

• REC opinion

  Further Information Favourable Opinion