Four-way randomised crossover study of LMTB vs MTC

• Research type

  Research Study

• Full title

  A Comparative Phase I Study to Evaluate the Relative Bioavailability and Pharmacokinetics of Leuco-methylthioninium Dihydrobromide (LMTB) and Methylthioninium Chloride (MTC) at Two Molar Equivalent Doses in Healthy Elderly Volunteers

• IRAS ID

  33169

• Contact name

  Stuart J Mair

• Sponsor organisation

  TauRx Therapeutics Limited

• Eudract number

  2009-016152-46

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will be conducted at Quotient Clinical on behalf of TauRx Therapeutics Ltd. The drug under investigation is LMTB which is being developed for the treatment of patients suffering from mild to moderate Alzheimer??s disease. LMTB is similar to Methylthioninium Chloride (MTC, commonly known as Methylene Blue) which has been in use worldwide for over 100 years. The main difference between LMTB and MTC is that the chloride salt in MTC is replaced with bromide in LMTB. The active ingredient, methylthioninium, is the same in both forms of the drug. The main objective of the study is to investigate the bioavailability of LMTB and MTC at two molar equivalent doses (i.e. compare how much LMTB and MTC are absorbed into the blood system). The secondary objectives are to assess how safe and well-tolerated LMTB is and study the absorption of both LMTB and MTC into the body. The study consists of a screening visit, 4 treatment periods, during which subjects will be resident in the clinic for 4 nights each, and one follow-up visit. Subjects will receive a single dose of IMP in each treatment period (i.e. 4 doses in total during the study). Two of the doses will be in tablet form, the other two will be provided as a capsule. The order in which these will be received will be randomised by a computer.As this study is a healthy volunteer study, there is not expected to be any benefit for participating subjects. The study will be reviewed by the MHRA and an independent Ethics Committee before the study starts.The study will be conducted across two Quotient Clinical sites - Edinburgh and Nottingham.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/28

• Date of REC Opinion

  8 Jan 2010

• REC opinion

  Favourable Opinion