Comparing blood levels after different dosing schedules of aramchol
Research type
Research Study
Full title
A randomised, open-label study to compare plasma concentrations of aramchol in healthy volunteers after once or twice daily oral dosing to steady state (HMR code: 18-023)
IRAS ID
255124
Contact name
Adeep Puri
Contact email
Sponsor organisation
Galmed Research and Development Ltd
Eudract number
2018-003854-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Aramchol (the study medicine) is an experimental treatment for non-alcoholic steatohepatitis (NASH). NASH is a type of non-alcoholic fatty liver disease (NAFLD), caused by the build-up of fat in the liver, which causes severe reduction in liver function. There are currently no treatments approved for NASH or NAFLD. Results from early clinical trials with the study medicine suggest it may be a useful treatment, reducing the amount of fat stored in the liver and reducing inflammation and scarring.
In this study, we’ll ask 16 healthy men and women, aged 18-45, to attend 2 study sessions. In each session they’ll take a total daily dose of 600 mg study medicine for 10 days. In one session they’ll take their dose as a single dose each morning and in the other session they’ll take their dose as twice-daily doses of 300 mg study medicine on Days 1–9 and a single 300 mg dose in the morning on Day 10. We’ll compare blood levels of the study medicine after each treatment schedule, to find out which treatment schedule will be most suitable for patients.
Participants will take up to 6 weeks to finish the study from their first admission to the ward. They’ll have 2 ward stays (24 nights in total) and make 2 outpatient visits.
A pharmaceutical company (Galmed Pharmaceuticals) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
18/NI/0192
Date of REC Opinion
26 Nov 2018
REC opinion
Further Information Favourable Opinion