To evaluate absorption, metabolism and excretion of C14-AZD8931

• Research type

  Research Study

• Full title

  [14C] AZD8931 – A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects

• IRAS ID

  69872

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2010-023994-20

• Research summary

  The drug being tested in this study is AZD8931. It is being developed as a possible treatment for cancer. AZD8931 is designed to interfere with specific pathways involved in cell growth that are known to be very active in many types of cancers. The primary objective are: to investigate the rate, route and extent of excretion of radioactivity in urine and faeces following single oral administration of AZD [14C] 8931.In this study AZD8931 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 is expected to involve a total of 6 healthy male volunteers. The study consists of three visits: enrolment visit (Visit 1), the residential period (Visit 2) and a follow up visit (Visit 3).The information gained in this study will help the sponsor of this study to determine whether AZD8931 is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/90

• Date of REC Opinion

  4 Jan 2011

• REC opinion

  Favourable Opinion