Single ascending dose study with LMTB including food effect

• Research type

  Research Study

• Full title

  A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled, Single Ascending Study of Leuco-Methylthioninium Dihydrobromide (LMTB) in Healthy Elderly Volunteers with a Single Dose Open, Fed vs. Fasting Crossover Evaluation

• IRAS ID

  32861

• Sponsor organisation

  TauRx Therapeutics Ltd.

• Eudract number

  2009-016150-41

• 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. This study is the first time that LMTB has been administered to humans. The main purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of LMTB after single doses in healthy elderly male and female volunteers. There are two parts to the study:Part 1 - Single Ascending DoseThe primary objectives are to evaluate the safety, tolerability and pharmacokinetics of 6 single ascending doses of LMTB, to identify possible dose limiting toxicities and to select two doses for a follow on multiple dose study. The secondary objective is to evaluate the pharmacokinetics of LMTB tablets administered as different strengths in healthy elderly volunteers. Two groups (each involving 12 subjects) will be randomised to receive a single dose of LMTB on three occasions. The two groups will be dosed in an alternating panel design. At each dose level, subjects will be randomised to LMTB or placebo containing 5 mg of LMTB.Part 2 - Food EffectThe primary objective is to investigate the relative bioavailability of LMTB at a selected dose level when given to 24 healthy elderly volunteers in either a fed or fasted state. Each subject will receive a single dose of IMP in two treatment periods. Subjects may be allowed to participate in both parts of the study.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/25

• Date of REC Opinion

  15 Dec 2009

• REC opinion

  Favourable Opinion