Multiple dose study with LMTB
Research type
Research Study
Full title
A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled, Multiple Dose Study of Leuco-Methylthioninium Dihydrobromide (LMTB) in Healthy Elderly Volunteers
IRAS ID
39107
Contact name
Stuart Mair
Contact email
Sponsor organisation
TauRx Therapeutics Limited
Eudract number
2009-017538-31
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 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/IEC02/29
Date of REC Opinion
8 Mar 2010
REC opinion
Further Information Favourable Opinion