AME study [14C]-MP-513 after single oral dose

• Research type

  Research Study

• Full title

  A phase I, open label, mass balance study to investigate the absorption, metabolism, and excretion of [14C]-MP-513 after a single oral dose in healthy male subjects

• IRAS ID

  38295

• Contact name

  Stuart J Mair

• Sponsor organisation

  Mitsubishi Tanabe Pharma Corporation

• Eudract number

  2009-015622-11

• Research summary

  This study will provide information on the levels of MP-513 in the blood and how the body breaks down and eliminates MP-513. Six healthy men will participate and receive one oral dose of 20 mg [14C]-MP-513(carbon 14[14C]) is a radiolabelled marker). After taking [14C]-MP-513 all urine and faeces will be collected, from which the radiolabelled marker Carbon 14 will be measured showing how much MP-513 is eliminated in urine and in faeces. As well as collecting urine and faeces, blood samples will be collected to measure the amount of MP-513 in the blood and plasma. Plasma will be also be analysed for breakdown products of MP-513, known as metabolites.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/26

• Date of REC Opinion

  17 Dec 2009

• REC opinion

  Favourable Opinion