To evaluate excretion, metabolism & pharmacokinetics of 14C-AZD 9668

• Research type

  Research Study

• Full title

  A Phase 1, Single Centre, Open -Label Study to Assess the Excretion, Metabolism and Plasma Pharmacokinetics following a single oral dose of 14C-AZD 9668 in Healthy Male Subjects.

• IRAS ID

  40558

• Contact name

  Tim Mant

• Sponsor organisation

  AstraZeneca

• Eudract number

  2009-017392-20

• ISRCTN Number

  Not submitted

• Research summary

  In this study we are investigating how the body 'handles', breaks down and eliminates a new drug, AZD 9668, which is of potential value in lung disease such as Chronic Obstructive Pulmonary Disease (COPD).COPD causes progressive difficulty with breathing. Its major cause is smoking. AZD 9668 has already been administered to healthy volunteers and patients. In this study a radioactive label (14C) is combined with AZD 9668 to enable detailed examination of its breakdown products and elimination from the body by examining blood, urine and faecal samples following a single dose by mouth. 4 healthy male volunteers aged greater than or equal to 50 will participate in the study. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. It will involve 3 visits over approximately 6 weeks, and will include 1 residential visit lasting 11 nights and 12 days, respectively. The follow up will be performed 5-7 days after collection of the last sample.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/130

• Date of REC Opinion

  10 Feb 2010

• REC opinion

  Further Information Favourable Opinion