An open-label, single-dose, crossover study in healthy male subjects.

• Research type

  Research Study

• Full title

  An open-label, single-dose, crossover study in healthy male subjects designed to assess the bioavailability of prototype extended release formulations of BC-3205 and the effect of food on the selected extended release formulation.

• Contact name

  Stuart J Mair

• Eudract number

  2009-011905-18

• 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 evaluate the safety, tolerability and pharmacokinetics of LMTB after multiple doses in healthy elderly volunteers. Two groups of 16 subjects (Groups 1 and 2) will be randomised to receive LMTB or placebo in a 3:1 ratio within each dosing group. Group 2 will start dosing 7 days after Group 1 (based on the safety and tolerability of the dose given to Group 1). An initial single dose will be administered, followed by 72 h of PK sample collections. Thereafter there will be a single dose on the evening of Day 4 followed by 14 consecutive days of BID (twice-daily) dosing. A final single dose will be administered on the morning of Day 19, followed by 72 h of PK sample collections. A follow up visit will take place for assessment of safety between 7 to 10 days after the last dose administration for each group. 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 two clinical sites of Quotient Clinical (Edinburgh and Nottingham) will be involved in this study.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/2

• Date of REC Opinion

  14 May 2009

• REC opinion

  Favourable Opinion