To investigate the safety and pharmacokinetics of AZD5069

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 after Administration of Multiple Ascending Doses for 8 days in Healthy Male or Female Subjects

• IRAS ID

  38365

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2009-015963-15

• ISRCTN Number

  xx

• Research summary

  The drug being tested in this study, AZD5069, is being developed for the possible treatment of chronic obstructive pulmonary disease (COPD). This will be the second study during which this drug will be given to human volunteers. This study plans to investigate the tolerability, safety and pharmacokinetics of a range of multiple oral doses of AZD5069 in healthy volunteers who are smokers.The study will take place at Quintiles Limited, Guy's Drug Research Unit. Up to 36 volunteers, in 3 groups of 12 each, will participate in the trial. Each volunteer will attend the unit for a single admission lasting 11 days, during which time they will receive AZD5069 on 14 occasions.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/115

• Date of REC Opinion

  11 Dec 2009

• REC opinion

  Further Information Favourable Opinion