AZD5069 Food and age Effect study

• Research type

  Research Study

• Full title

  A Phase I, two-part study to investigate the effects of food on the PK of a single oral dose of AZD5069 in healthy adult volunteers (Part A) and to compare the PK of AZD5069 in adult and elderly healthy volunteers (Part B)

• IRAS ID

  44415

• Contact name

  Tim Mant

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2009-017963-40

• Research summary

  AZD5069 is a new drug being tested for the possible treatment of people with chronic obstructive pulmonary disease (COPD). You might know this disease better as emphysema or chronic bronchitis. AZD5069 is a new drug being developed for the treatment of COPD. This is not the first time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine the safety, tolerability and pharmacokinetics (how the body handles the drug) of AZD5069 on healthy males and females in fed and fasted states. We will compare between the age groups of 18 to 65 years and above 65 years. The study will be conducted at Quintiles Drug Research Unit, London and involves two parts Part A and Part B. Part A The study involves 4 visits over approximately 6 weeks, and will include 2 residential visits lasting 3 nights each and a follow up. It is planned that there will be up to 16 volunteers in 2 groups of 8 each. Volunteers will receive AZD5069 following overnight fasting on one admission and following breakfast on the other admission. Volunteers will receive AZD5069 once only on each admission. Part B The study involves 3 visits over approximately 5 weeks, and will include 1 residential visit lasting 3 nights and a follow up. It is planned that there will be up to 8 volunteers in this study group. There will be one admission period and volunteers will receive120 mg of AZD5069 once only following overnight fasting and continue to fast for 4 hours after receiving AZD5069.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/3

• Date of REC Opinion

  1 Feb 2010

• REC opinion

  Favourable Opinion