To investigate safety and pharmacokinetics of inhaled AZD5423

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD5423 after Single Ascending Doses in Healthy Male Subjects.

• IRAS ID

  26355

• Contact name

  Darren Wilbraham

• Eudract number

  2009-012507-26

• ISRCTN Number

  xx

• Research summary

  The drug being tested in this trial is AZD5423. It is being developed as a possible treatment for patients with asthma and chronic obstructive pulmonary disease (COPD -i.e. chronic bronchitis and emphysema). This will be the first time AZD5423 will be given to man. The main purpose of this study is to determine how safe AZD5423 is and how well it is tolerated in healthy male subjects. In addition, we will measure the levels of AZD5423 in the blood and the effect of AZD5423 on the hormone cortisol. We may also investigate what AZD5423 is broken down into, by analysing blood and urine samples collected during the study. Up to 72 healthy, non-smoking men aged 18 to 45 will be enrolled in the study. The study will take place at Guy's Drug Research Unit, Quintiles Ltd. It will involve 4 visits over approximately 5 weeks, and will include 2 residential visits lasting 2 nights and 3 nights, respectively. The follow up will be performed 7 - 13 days after dosing. The information gained in this study will help the sponsor of this study to determine whether AZD5423 is suitable for further studies in humans.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/79

• Date of REC Opinion

  17 Aug 2009

• REC opinion

  Further Information Favourable Opinion