ADME study with [14C]BAY 73-4506 (regorafenib) in healthy subjects

• Research type

  Research Study

• Full title

  Single center, open-label, non-randomized, non-placebo-controlled study to investigate the metabolism, excretion pattern, mass balance, safety, tolerability and pharmacokinetics of 120 mg [14C]BAY 73-4506 (regorafenib) after single dose oral administration in healthy male subjects

• IRAS ID

  46374

• Contact name

  Stuart Mair

• Sponsor organisation

  Bayer Healthcare AG

• Eudract number

  2010-019120-31

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The drug that is under investigation during this study is regorafenib (BAY 73-4506) which is intended to be used as a treatment for patients suffering from advanced cancer. The purpose of this study is to define the excretion of radiolabelled BAY 73-4506 and its breakdown products by measuring the concentration in blood, urine and faeces over a 10-14 day period. Other objectives of the study are to provide information on the levels of unchanged BAY 73-4506 in the blood and to provide additional safety and tolerability information on the drug. Four healthy male volunteers (with a maximum of two additional replacement subjects if necessary) between 30 and 65 years of age who meet the inclusion criteria will participate in the study. The study consists of a screening visit and one dosing/in-patient observation period, during which the subjects will be resident for 11 to 15 nights. If necessary, subjects may be asked to continue collecting urine and faecal samples at home for up to 7 days. Each subject will receive one oral dose of 120 mg [14C] BAY 73-4506 (carbon 14 or [14C] is a radiolabelled marker). After taking the study drug, all urine and faeces will be collected, from which the radiolabelled marker Carbon 14 will be measured to show how much BAY 73-4506 is eliminated in urine and in faeces. In addition, blood samples will be collected to measure the amount of BAY 73-4506 in the blood and plasma. Blood, urine and faeces will be also be analysed for breakdown products of BAY 73-4506, known as metabolites. This study will be conducted at one site, Quotient Clinical Edinburgh.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/18

• Date of REC Opinion

  30 Nov 2010

• REC opinion

  Favourable Opinion