Gastric pH PPI
Research type
Research Study
Full title
A Phase I, Open Label Study to Assess the Effects of Increased Gastric pH on the Pharmacokinetics of LMTM in Healthy Subjects
IRAS ID
206112
Contact name
Chamikara Fernando
Contact email
Sponsor organisation
TauRx Therapeutics Ltd
Eudract number
2015-005447-13
Duration of Study in the UK
0 years, 1 months, 12 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 the effect of gastric pH (stomach acidity) on LMTM absorption in healthy volunteers. To assess this, a medication called Pantoprazole ( a marketed drug) will be used.
Twenty-eight healthy male and female volunteers will be enrolled.
Volunteers will undergo study specific screening within the 28 days prior to dosing. Eligible volunteers will be admitted to the Clinical Research Unit (CRU) on Day -1, and will reside at the CRU until the morning of Day 3.
Volunteers will return to the CRU for outpatient visits on Days 4 and 5, and Days 8 to 12; on the morning of Day 13, volunteers will again be admitted to the CRU, and will reside at the CRU until the morning of Day 16.
Volunteers will again return to the CRU for outpatient visits in the morning of Days 17 and 18. All volunteers will then be required to return to the CRU 5 to 7 days after their final dose of study drug..
Each volunteer will receive a single oral dose of 250 mg LMTM on the morning of Day 1 under fasting conditions.
On the morning of Day 8, volunteers will commence the multiple dose regimen for pantoprazole, where volunteers are to receive 40 mg pantoprazole once daily on a until Day 12 ; the final 2 doses on Days 13 and 14 will be administered in a fasting state while the volunteers are housed. On the morning of Day 14, volunteers will receive a single oral dose of LMTM co administered with pantoprazole under fasting conditions.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0141
Date of REC Opinion
16 Jun 2016
REC opinion
Further Information Favourable Opinion