Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to compare two different aramchol formulations in healthy volunteers.

This research study is looking at two slightly different forms of a drug called aramchol. We want to understand how healthy people's bodies react to these new versions. This type of study, often called a Phase 1 study, is the first step in humans to check if a new medicine is safe and how it behaves in the body. The information gathered will be used to help develop better treatments for liver problems such as non-alcoholic fatty liver disease (NAFLD) and primary sclerosing cholangitis (PSC). These conditions can cause serious damage to the liver, and finding effective treatments is very important. Taking part means helping to advance medical science for future patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Galmed Research And Development Ltd.

Enrolment target

Start

13 Dec 2024

Nonalcoholic fatty liver disease Nonalcoholic steatohepatitis Primary sclerosing cholangitis

What is this study about?

This study is a very early step in understanding a new medicine called aramchol. Think of it like a test drive for a new car – before it can be sold to the public, experts need to see how it performs in a controlled setting. In this case, we're not testing a car, but two slightly different versions of a potential drug.

The main goal is to see if these new versions of aramchol are safe for people to take and to learn how the body processes them. This includes how much of the drug gets into the bloodstream, how long it stays there, and how the body gets rid of it. Because this is so early in development, we test it in healthy volunteers first – people who don't have the illnesses the drug is designed to treat. This helps us understand its basic safety and how it works without the complexities of an illness.

Why does this matter? Aramchol is being studied as a potential treatment for serious liver conditions like non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and primary sclerosing cholangitis (PSC). These conditions can lead to liver damage and other health problems. By understanding how these new drug forms work in healthy people, researchers can then move on to testing them in people with these liver conditions, hoping to find safer and more effective ways to help them. Your participation helps lay the groundwork for these important future treatments.

Key takeaways

This study is testing two forms of a drug called aramchol in healthy people.
It's a very early-stage study (Phase 1) focused on safety and how the body handles the drug.
The findings could help develop future treatments for liver diseases like fatty liver disease.
Participation involves clinic visits, blood tests, and health checks.
You must be at least 18 years old and generally healthy to be considered.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, meaning anyone over 18 can potentially join if they meet other requirements.

This study is open to both men and women. Because this is a very early-stage study looking at safety, you would need to be generally healthy. This means you wouldn't have any major ongoing health problems or be taking medications that might interfere with the study drug.

The research team will carry out several checks and ask detailed questions about your health to make sure this study is right for you and that you meet all the specific entry requirements. It's really important for your safety and the accuracy of the study results that everyone participating is a good fit.

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 18 years old or older?
Are you generally healthy, without any major ongoing medical conditions?
Are you able to attend several appointments at a study clinic?
Are you willing to have blood tests and other routine health checks?
Are you not currently taking any medications that might interfere with a study drug (this will be checked by the study team)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive one of the two different versions of the aramchol drug. This study is designed to check how your body handles the drug, so it would involve several visits to the clinic. At these visits, you might have blood samples taken to measure the drug levels in your body, and you'll have regular health checks like blood pressure and heart rate measurements. You would also be asked about any side effects you might experience.

The exact number and duration of visits would be explained in full detail by the study team, but typically, early-stage studies like this involve detailed monitoring over a specific period, which could range from a few days to a few weeks, with some follow-up appointments. You'd be monitored closely throughout to ensure your safety and to gather as much information as possible about the drug.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical research that could one day lead to new treatments for serious liver conditions. You will also receive careful medical monitoring. Potential risks might include common side effects from the study drug, which could be mild, like feeling tired or having an upset stomach, or more serious, though serious side effects are rare and carefully tracked. There might also be discomfort from assessments like blood draws. You have the right 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.

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Unverified
Bulgaria

Common questions

What is aramchol?

Aramchol is a drug being studied as a potential treatment for certain liver diseases. This study is an early step to see how safe it is and how it works in healthy people.

What is 'Phase 1' of a study?

Phase 1 is the first time a new medicine is tested in people. It's mainly to check if it's safe and to understand how the body handles it, usually in healthy volunteers.

What are non-alcoholic fatty liver disease (NAFLD) and primary sclerosing cholangitis (PSC)?

These are conditions that can affect the liver. NAFLD means there's too much fat in the liver, and PSC is a rare disease where the bile ducts inside the liver become inflamed and scarred. This study aims to help find treatments for these and similar conditions.

Will I get the active drug or a dummy drug (placebo)?

This study is comparing two different versions of the aramchol drug. You would receive one of these active versions, not a dummy drug, as the aim is to understand how the drug works in your body.

Do I need to have a liver condition to join?

No, this specific study is looking for healthy volunteers. The aim is to understand the drug's basic safety and how it works before testing it in people with liver conditions.