BP25280 (QBR106370)

• Research type

  Research Study

• Full title

  Single-center, open-label study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO4995819 and an intravenous microdose of [13C]-labeled RO4995819 in healthy male volunteers.

• IRAS ID

  63413

• Contact name

  Stuart J Mair

• Sponsor organisation

  F. Hoffmann-La Roche Ltd.

• Eudract number

  2010-021335-13

• Research summary

  Study drug RO4995819 is under development for the treatment of depression.Further development of RO4995819 is required for which greater knowledge of the metabolism (breakdown) and excretion (elimination) in man is required. This study will provide information on the levels of RO4995819 in the blood and how the body breaks down and eliminates RO4998452. Six healthy men will participate and receive one oral dose of 25 mg [14C]RO4998452 (carbon 14[14C]) is a radiolabelled marker, and one 30 minute intravenous infusion of 0.1 mg [13]C RO4998452.After taking [14C]RO4998452 all urine and faeces will be collected, from which the radiolabelled marker Carbon 14 will be measured showing how much RO4995819 is eliminated in urine and in faeces.The 13C iv microdose allows comparison of the availability of RO4995819 to the body when given orally and intravenously.As well as collecting urine and faeces, blood samples will be collected to measure the amount of RO4995819 in the blood and plasma. Plasma will be also be analysed for breakdown products of RO4998452, known as metabolites.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/25

• Date of REC Opinion

  12 Oct 2010

• REC opinion

  Further Information Favourable Opinion