A study to assess the mass balance of [14C]-MT-1303 in HVs MT-1303-E11

• Research type

  Research Study

• Full title

  An open-label, mass balance study to investigate the absorption, metabolism and excretion of [14C]-MT-1303 after a single oral dose to healthy male subjects

• IRAS ID

  159854

• Contact name

  Pui Leung

• Contact email

  pui.leung@quotientclinical.com

• Sponsor organisation

  Mitsubishi Tanabe Pharma Corporation (MTPC)

• Eudract number

  2014-000645-75

• Research summary

  The Sponsor is developing the study drug, MT-1303, for the potential treatment of multiple sclerosis (MS), psoriasis, inflammatory bowel disease (IBD) and systemic lupus erythematosus (SLE).

  The purpose of the study is to look at how radiolabelled MT-1303 is taken up, broken down and removed from the body when given as an oral solution (by mouth).

  The study will consist of 1 part involving up to 9 healthy male subjects. Subjects will receive a dose of 0.4 mg of [14C]-MT-1303.

• REC name

  Wales REC 2

• REC reference

  14/WA/1086

• Date of REC Opinion

  27 Aug 2014

• REC opinion

  Further Information Favourable Opinion