The absorption,excretion & pharmacokinetics of 14C-AZD5069

• Research type

  Research Study

• Full title

  A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers

• IRAS ID

  75200

• Contact name

  Tim Mant

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-000458-45

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The drug being tested in this study is AZD5069. It is being developed as a possible treatment for developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The primary objective of the study is to characterise how the body handles AZD5069. In this study AZD5069 is joined with radioactive carbon. This allows us to track tiny quantities of the drug and its breakdown products and determine how long they remain in the body. By measuring the drug in faeces and urine we can determine how the drug is eliminated from the body. The study will take place at Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd. The study involves 3 visits to the research unit, with a pre-study screening visit, admission period and a post-study follow-up visit. The study is expected to involve a total of 6 healthy male volunteers. 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

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0021

• Date of REC Opinion

  28 Apr 2011

• REC opinion

  Further Information Favourable Opinion