QBR111723 (TRx-237-009)

• Research type

  Research Study

• Full title

  A phase 1 study to investigate the absorption, metabolism and excretion following single oral administration of [14C]- leuco-methylthioninium (bis)hydromethanesulfonate (LMTM) to healthy male volunteers

• IRAS ID

  85282

• Contact name

  Stuart J Mair

• Sponsor organisation

  TauRx Therapeutics Ltd

• Eudract number

  2011-003138-14

• Research summary

  TRx0237 is being developed by TauRx Therapeutics Ltd as a treatment for Alzheimer's disease. The purpose of the study is to look at how radiolabelled TRx0237 is taken up, broken down and removed from the body when given as an oral capsule (by mouth). ??Radiolabelled? means that the test drug has a radioactive addition which allows us to track the drug. Blood, urine and faecal samples will be taken at specific times throughout the study to look at the concentrations of drug in the body. A single cerebrospinaflud sample will also be collected to look at concentration of the drug there.The safety and tolerability of the test drug will also be assessed.

• REC name

  Scotland A REC

• REC reference

  11/IE/0122

• Date of REC Opinion

  8 Sep 2011

• REC opinion

  Further Information Favourable Opinion