Comparison of aramchol concentrations with aramchol meglumine and acid
Research type
Research Study
Full title
A 3-part, Phase I, open-label, randomised, study comparing single and repeated doses of Aramchol meglumine with Aramchol acid tablet (reference) and Aramchol meglumine fed and fasted in healthy volunteers (20-010)
IRAS ID
287789
Contact name
Adeep Puri
Contact email
Sponsor organisation
Galmed Research and Development, Ltd.
Eudract number
2020-003721-34
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Summary of Research\nAramchol (the study medicine) is an experimental treatment for non-alcoholic steatohepatitis (NASH). NASH is a type of liver disease due to build-up of fat in the liver, which causes inflammation and scarring. There are currently no available treatments for NASH but early clinical trials suggest that the study medicine may be of benefit by reducing liver fat and scarring. We’re doing this study to compare 2 forms of aramchol: an existing tablet and a new capsule. We hope that the new capsule will dissolve more quickly in the stomach so that more aramchol gets into the bloodstream. \n\nThis is a 3-part study in healthy volunteers, aged 18-45.\n\nPart 1: 18 volunteers will have 3 study sessions when they’ll receive a single oral dose of aramchol, as the tablet, as a single capsule and as two capsules.\n \nPart 2: 12 volunteers will have 2 study sessions, when they’ll take a single dose of the aramchol capsule after fasting or after breakfast. \n \nPart 3: up to 24 volunteers will have 2 study sessions, when they’ll receive doses of aramchol daily for 10 days, either as a capsule or tablet. \n\nWe aim to find out the side effects and blood levels of the different aramchol forms and to test if food affects blood levels of aramchol after swallowing the capsule.\nVolunteers may only participate in one part of the study. In Parts 1 and 2 they’ll stay on the ward for 4 days and 3 nights followed by a daily visit for 5 days in each session. In Part 3 participants will stay on the ward for 11 nights in each of the 2 sessions.\n\nA pharmaceutical company (Galmed Research & Development Ltd) is funding the study. \n \nThe study will take place at 1 centre in London.\n\nSummary of Results\nThis was a Phase 1 trial in healthy volunteers with no therapeutic intent. For reasons of commercial confidentiality a lay summary of the trial results is not provided
REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0302
Date of REC Opinion
2 Oct 2020
REC opinion
Further Information Favourable Opinion