To assess safety/tolerability and PK/PD of inhaled AZD8683

• 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 inhaled AZD8683 after Single Ascending Doses administered via TurbuhalerTM in Healthy Subjects

• IRAS ID

  83930

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-002412-87

• ISRCTN Number

  Unknown

• Research summary

  The drug being tested in this study, AZD8683, is being developed for the possible treatment of chronic obstructive pulmonary disease (COPD) ?? a smoking related lung disease. This is not the first time this drug has been given to healthy volunteers. This study plans to investigate how safe and well tolerated this new medication is, and how much of it enters the blood circulation by collecting blood and urine samples. The study will take place at Quintiles Drug Research Unit at Guy??s Hospital. Approximately 40 volunteers will participate in the study. There will be 4 groups of 8 volunteers, each receiving a single dose of AZD8683. Each volunteer will attend the unit for a single admission lasting 4 days.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1151

• Date of REC Opinion

  14 Sep 2011

• REC opinion

  Further Information Favourable Opinion