RecruitingPHASE1INTERVENTIONAL

Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet

This research study is for healthy adult volunteers and focuses on a new medicine called Aramchol. We're testing a tablet form of Aramchol to understand how your body handles it. This includes looking at how much of the medicine gets into your system after taking different single doses. We also want to compare how much medicine is in your body after taking it regularly once a day, versus a different form of Aramchol taken twice a day. This type of study, called a Phase 1 trial, is really important for working out the safest and most effective way to give new medications before they are tested in people with specific health conditions.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Galmed Pharmaceuticals Ltd

Enrolment target

Start

25 Dec 2025

Estimated completion

15 May 2026

Healthy

What is this study about?

This study is a type of early-stage research often called a 'Phase 1' trial. Its main goal is to understand how your body deals with a new medicine called Aramchol, which is being given in a new tablet form. We're not testing Aramchol to treat any specific illness in this study, but rather to learn about its basic properties in healthy people. Think of it like learning how a new car engine works before you put it on the road – we need to know how the fuel (Aramchol) is used and what comes out.

Specifically, researchers want to see how much Aramchol gets into your blood at different times after you take a single tablet. They'll be trying out two different single doses to see if a higher dose means more medicine in your system. This helps them understand the best dose to start with.

Another part of the study involves comparing how much Aramchol builds up in your body when you take it every day for a while, versus a different version of Aramchol that was previously taken twice a day. This information is crucial for figuring out the best and most convenient way for people to take Aramchol in the future, if it proves effective for other conditions. All this information is vital for developing new medicines safely and effectively.

Key takeaways

This is an early-stage study (Phase 1) of a new medicine called Aramchol.
It's for healthy adult volunteers, not people with a specific illness.
The main goal is to understand how the body handles different doses of Aramchol.
Participation involves taking tablets and having regular health checks and blood tests.
You'll be helping medical research to develop new medicines.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for healthy men and women between the ages of 18 and 55. To be considered, your body weight and height must fall within a healthy range, known as a Body Mass Index (BMI) between 18 and 30.9.

Before you can join, a doctor will check your overall health through a medical history, a physical exam, a heart tracing (ECG), blood pressure and pulse, and blood and urine tests. You'll need to be in good health based on all these checks. If you are a woman who could become pregnant, you will need to agree to use reliable contraception throughout the study, and women who are pregnant or breastfeeding cannot take part.

You won't be able to join if you have certain health conditions like hepatitis B, C, or HIV, or if you've had a severe reaction to medicines in the past. People who have used drugs, smoked, or regularly drink too much alcohol recently are also not suitable. If you have any serious or ongoing illnesses, or if your blood or urine tests show anything concerning, you wouldn't be able to participate. It's also important that you are able to understand and follow all the study instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Do you consider yourself generally healthy?
Is your weight within a healthy range for your height?
Are you a non-smoker, and have you not smoked in the last 3 months?
Are you able to attend appointments and follow instructions?
If you are a woman who could become pregnant, are you willing to use reliable contraception during the study?

Answer every question to see your result.

What does participation involve?

If you take part, you'll be given the study medicine, Aramchol, in tablet form. You will be monitored closely to see how your body reacts to it and how much of the medicine is in your blood over specific time periods. This will involve giving blood samples at set times. You will be asked to attend clinic visits for these assessments, and your overall health will be checked regularly through physical exams, vital signs, and laboratory tests. The study will involve taking single doses at first, and then potentially taking a dose daily for a period. The total duration of your involvement in the study will be explained in full detail by the study team.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical science and helping to understand how new medicines work, which could lead to new treatments for others in the future. As with any medicine, there's always a possibility of side effects, which you will be fully informed about before deciding to participate. The study team will monitor you closely for any health changes. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hammersmith Medicines Research (HMR)
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Aramchol?

Aramchol is the name of a new medicine being studied. This research specifically looks at a new tablet form of it.

Why is this study for healthy people?

Studies in healthy people help researchers understand how a new medicine works in the body and if it's generally safe before testing it in people with specific illnesses.

Will I get paid for taking part?

This information isn't provided here, but most clinical trials offer some payment for your time and travel. This would be explained fully by the study team.

How long will I need to be involved?

The exact duration isn't specified here, but it will involve some clinic visits for monitoring and taking the medicine. The study team will give you a detailed timeline.

What kind of tests will I have?

You'll have physical check-ups, blood and urine tests, and an ECG (heart tracing) to ensure you're healthy and to monitor you during the study.

How to find out more

Yossi Gilgun-Sherki, PhD, MBA

yossigs@galmedpharma.com 0543314054 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.