A Phase I Study to Determine Bioavailability of AZD8931

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II wet granulation tablet formulation compared to the Phase II/III roller compacted tablet formulation of AZD8931

• IRAS ID

  75189

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-000747-24

• Research summary

  AZD8931 is a new drug being tested for the possible treatment of people with cancer. AZD8931 is designed to interfere with specific pathways involved in cell growth, known to be very active in many types of cancers. AZD8931 is being developed with the expectation that it will provide superior treatment in cancer compared to currently available treatments. In this study we will compare 2 oral formulations of AZD8931. Recent studies have involved the administration of a granulated tablet. It is anticipated that ongoing and future studies will use a compacted tablet formulation of AZD8931. Therefore, we need to compare both these formulations to ensure the way in which they are handled by the body are similar. 28 healthy male and non fertile female volunteers aged 18 - 55 years will participate in the study. The study will involve 2 admission periods to Quintiles drug Research Unit. During each period subjects will receive 1 dose of AZD8931.

• REC name

  Scotland A REC

• REC reference

  11/IE/0034

• Date of REC Opinion

  28 Mar 2011

• REC opinion

  Further Information Favourable Opinion