Effect of aramchol on blood levels of midazolam and atorvastatin, v1
Research type
Research Study
Full title
Study of potential for drug interactions mediated by CYP3A4 inhibition with aramchol in healthy volunteers (18-016)
IRAS ID
253694
Contact name
Adeep Puri
Contact email
Sponsor organisation
Galmed Pharmaceuticals Ltd
Eudract number
2018-003444-23
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The study medicine (aramchol) 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 aramchol suggest it may be a useful treatment, reducing the amount of fat stored in the liver and reducing inflammation and scarring.
Many medicines are broken down in the liver by substances called enzymes. Sometimes, taking 2 or more medicines together can affect how quickly enzymes break down the medicines, and how long it takes the body to get rid of them. We’re doing this study in healthy people to find out if aramchol affects the way the body handles 2 existing ‘test’ medicines, called midazolam and atorvastatin that are broken down by enzymes in the liver.
We’ll recruit 16 healthy men, aged 18-45. They’ll have 2 sessions. In session 1, they’ll take single doses of 2 mg midazolam and 40 mg atorvastatin alone, on Days 1 and 3 respectively. In session 2, they’ll take twice-daily doses of 300 mg aramchol, each morning and evening, for 18 days, with a single dose of 2 mg midazolam on Day 10, and a single dose of 40 mg atorvastatin on Day 12. We’ll compare blood levels of the test medicines with and without aramchol, to find out whether aramchol affects breakdown of medicines by liver enzymes.
Participants will take up to 6 weeks to finish the study from their first admission to the ward. They’ll have 2 ward stays (29 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/0177
Date of REC Opinion
18 Oct 2018
REC opinion
Favourable Opinion