Effects of oral doses of AZD5069 on neutrophil numbers

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils into the Circulation after Exercise and Subcutaneous G-CSF

• IRAS ID

  92071

• Contact name

  Tim Mant

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-004813-18

• Research summary

  The drug being tested is AZD5069. It is being developed as a possible treatment for Chronic Obstructive Pulmonary Disease (COPD). The primary objective of the study is to investigate whether the function of neutrophils in the blood circulation (while on treatment with AZD5069) remain unaffected and whether there is the usual increase in numbers of neutrophils in the blood when exposed to stimuli in the form of exercise and G-CSF. G-CSF is a licensed medication which is injected under the skin to increase the number of neutrophils in the blood. CXCR2 (CXC chemokine receptor-2) is a receptor expressed on the blood cells which contributes to the lung damage (inflammation) seen in COPD. AZD5069 has been shown to be very specific at blocking the CXCR2 receptor. This results in reduction in the number of neutrophils (a type of white blood cells contributing to inflammation) in the tissues of the lung. This will hopefully reduce lung inflammation in COPD. This is not the first time that AZD5069 will be administered to humans in clinical trials The study will take place at Quintiles Drug Research Unit London. The study is expected to involve 30 healthy Caucasian male or female (of non-childbearing potential) volunteers. The duration of participation is approximately 11 weeks. The study involves 5 visits to the research unit, with a screening visit, admission period (treatment 1), outpatient visit, admission period (treatment 2) and a post study follow-up visit. The total volume of blood to be taken from each subject will be no greater than 550 mL for the whole study. Each participant would be compensated œ2200 for their time and inconvenience. The information gained in this study will help the sponsor of this study to determine whether AZD5069 is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/1640

• Date of REC Opinion

  23 Nov 2011

• REC opinion

  Further Information Favourable Opinion