Phase I, safety/tolerability/ pk of AZD3199 in Japanese men

• Research type

  Research Study

• Full title

  A phase I, randomised, double-blind, placebo-controlled, parallel-group, single-centre study to investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of AZD3199 given once daily as inhaled formulation via Turbuhaler to Japanese healthy men

• IRAS ID

  7040

• Contact name

  Ronnie Beboso

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2008-004448-35

• Research summary

  AZD3199 is a new bronchodilator drug being developed as a possible treatment for patients with asthma and Chronic Obstructive Pulmonary Disease (COPD). In patients who have asthma the respiratory airway occasionally narrows, becomes inflamed, and is lined with excessive amounts of mucus in response to one or more triggers such as specific allergens, viral infections, exercise and inhaled irritants like tobacco smoke. This causes symptoms such as wheezing, shortness of breath, chest tightness, and coughing. COPD involves ??inflammation? of the airways in the lungs which means that some cells in the lung are ??overactive? and cause damage to the lungs that is not fully reversible and can be caused by smoking. The most common medicines used for the treatment of asthma and COPD are drugs that open up and dilate the airways (bronchodilators) and inhaled steroids, which help reduce airway inflammation. We are doing this study to find out how the body handles AZD3199, ie, how quickly the body absorbs and removes the drug and also how well the body tolerates it. One of the most important parts of this study is to see how Japanese volunteers take up the drug and how it is removed by the body. AZD3199 has been given to healthy Caucasian male volunteers and asthmatics in previous studies. It has been given safely in single doses up to 1280 micrograms. There is another multiple dose study being performed in parallel to this study in Caucasian volunteers. In study in patients with mild asthma, no safety concerns were observed when AZD3199 was given as a single dose. Twenty seven subjects (3 cohorts of 9 volunteers each) of Japanese descent will be taking part in this study at a single centre in the UK. You will not be able to choose which cohort you are allocated to.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  08/S1402/53

• Date of REC Opinion

  30 Oct 2008

• REC opinion

  Further Information Favourable Opinion