LMTM DDI Study
Research type
Research Study
Full title
A Phase I, Open-Label Study to Determine the Effect of LMTM on the Pharmacokinetics of Digoxin in Healthy Subjects
IRAS ID
189945
Contact name
Chamikara Fernando
Contact email
Sponsor organisation
TauRx Therapeutics Ltd
Eudract number
2015-005332-17
Duration of Study in the UK
0 years, 1 months, 11 days
Research summary
LMTM is an investigational medicinal product which has already been tested in humans. LMTM is a potential treatment for patients with dementia such as Alzheimer’s disease. Dementia describes a loss of mental ability associated with gradual death of brain cells.
This study to evaluate interaction of LMTM with a medication called Digoxin. Digoxin is a marketed drug and commonly used in patients with heart diseases.
Twenty-two healthy male and female volunteers will be enrolled on this study.
Each volunteer will reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours post-dose), and from Day 20 to Day 23. Volunteers will be required to return to the CRU on an outpatient basis on Days 4, 5, 6, 7, 8, 9, 10, 14, 17, 19, 24, 25, 26, 27, 28 and 29.
All volunteers will return for post-study assessments 5 - 7 days post-final dose. The total duration for each volunteer will not exceed 61 days.
Volunteers will receive a single 0.25mg dose of digoxin on the morning of Day 1 and on the morning of Day 21, in the fasted state. Volunteers will receive twice daily (BID) 225-mg doses of LMTM on Day 7 to Day 26. On Day 21, the digoxin dose will be co-administered with the LMTM morning dose.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0012
Date of REC Opinion
5 Apr 2016
REC opinion
Further Information Favourable Opinion