Oral Bioavailability and ADME of Debio 0932 (QBR113845)

• Research type

  Research Study

• Full title

  A Two-Part, Sequential Design Study to Determine Debio 0932 Absolute Oral Bioavailability, Mass Balance Recovery, Metabolite Profiling and Structural Identification in 3 Cohorts of Healthy Male Subjects

• IRAS ID

  114635

• Contact name

  Stuart Mair

• Sponsor organisation

  Debiopharm SA

• Eudract number

  2012-003495-39

• Research summary

  The purpose of the study is to investigate a drug called Debio 0932 which is being developed for the treatment of cancer. This study has been split into two parts. Part 1 will involve 2 groups of 6 male volunteers and will look at how two different amounts of Debio 0932 (the study drug) are taken up by the body when given by mouth compared to when the study drug is given directly into a vein in the arm. This part will also look at how well the study drug is tolerated by the body and how it is broken down by the body. Part 2 will look at how Debio 0932 is taken up, broken down and removed from the body when given by mouth in up to 8 male volunteers. The safety and tolerability of the test drug will also be assessed. In part 1, the dose of Debio 0932 given into the vein will contain a small amount of radiolabel. In part 2, the dose given by mouth will contain a radiolabel. ????Radiolabelled???? means that the study drug has a radioactive component that helps us to track the drug. The radiolabelled material that will be used is Carbon-14 (14C) in both parts. Blood, urine and faecal samples will be taken at specific times throughout the study to look at amounts of the study drug in the body.

• REC name

  HSC REC B

• REC reference

  12/NI/0141

• Date of REC Opinion

  4 Oct 2012

• REC opinion

  Further Information Favourable Opinion