Effect of LMTM on CYP450 Substrates & a P-gp in Volunteers

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Parallel Study Evaluating the Effect of LMTM on Cytochrome P450 (CYP450) Enzyme Substrates and a P-Glycoprotein (P-gp) Substrate Using a Validated Four-Drug Cocktail, Four Separate CYP450 Substrates, and One P-gp Substrate Administered to Healthy Adult Volunteers.

• IRAS ID

  98479

• Contact name

  Simon L Singer

• Sponsor organisation

  TauRx Therapeutics Ltd.

• Eudract number

  2011-006039-43

• Research summary

  This study will be conducted in healthy male and female volunteers at a Phase I unit in Manchester. The purpose of this trial is to assess a new drug LMTM that is being developed for the treatment of Alzheimer??s disease. It is very similar to methylene blue (MTC), a drug that has been used in medicine for approximately 100 years. It is intended to assess whether LMTM affects the way certain drugs are broken down as well as assessing the levels of the drug in the bloodstream at various time points and safety of the new drug.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0194

• Date of REC Opinion

  18 Apr 2012

• REC opinion

  Further Information Favourable Opinion