Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Drug-Drug Interaction Study With BIA 28-6156 and Clarithromycin, Midazolam, and Dabigatran Etexilate in Healthy Participants

This study is a Phase 1 clinical trial designed to understand how a new medicine, BIA 28-6156, interacts with some commonly prescribed drugs. These drugs are clarithromycin (often used for infections), midazolam (a type of sedative), and dabigatran etexilate (used to prevent blood clots). The main goal is to find out if taking BIA 28-6156 at the same time as any of these other medicines changes how they work in the body, or how the body handles them. This is very important for safety, so that doctors will know how to prescribe these medicines together without unexpected side effects. We are looking for healthy volunteers to help us with this research.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bial Portela & Ca S.A.

Enrolment target

Start

08 Apr 2025

Healthy volunteers

What is this study about?

When new medicines are developed, it’s really important to find out how they behave when people take them with other drugs. This study is specifically designed to look at a new medicine called BIA 28-6156 and see if it interacts with three other common drugs: clarithromycin (an antibiotic), midazolam (a medicine sometimes used to help with anxiety or for medical procedures), and dabigatran etexilate (a blood-thinning medicine).

The main aim is to understand if taking BIA 28-6156 at the same time as these other medicines changes how they work in your body. For example, it might make one of the medicines stronger or weaker, or it might change how quickly your body gets rid of the medicine. This is a very early stage of testing, known as a Phase 1 study, and it's done partly to ensure that if BIA 28-6156 is eventually approved for use, doctors will know how to prescribe it safely alongside these other common medications.

By taking part, healthy volunteers help scientists gather crucial information before this new drug can be offered to patients who need it. This research is a key step in developing safe and effective treatments for the future.

Key takeaways

This study checks how a new drug interacts with common medicines.
It uses healthy volunteers to understand drug safety.
It's an early-stage (Phase 1) study.
Your participation helps develop safe future treatments.
You need to be 18 or older to take part.

Who may be eligible?

This study is looking for healthy adults to take part. This means we are seeking people who generally don't have any major health problems.

To be eligible, you need to be at least 18 years old. There's no upper age limit, as long as you meet the other health requirements.

Both men and women can take part in this study. The research team will carefully check your health to make sure it's safe for you to join.

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 at least 18 years old?
Do you consider yourself generally healthy?
Are you able to attend appointments at a study clinic?
Are you comfortable with blood tests and taking study medicines?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be given doses of BIA 28-6156, along with one or more of the other study medications (clarithromycin, midazolam, or dabigatran etexilate) at different times. You will need to visit the study clinic regularly, which might involve staying overnight for some parts of the study. During these visits, the study team will take blood samples to measure how the medicines are behaving in your body. They will also check your general health, such as blood pressure and heart rate, and ask you about how you are feeling. The total duration of your involvement in the study will be explained in detail by the research team.

Potential risks and benefits

Taking part in any study involves some potential benefits, such as contributing to medical knowledge that could help future patients. There might be some potential risks, like side effects from the medicines or discomfort from blood tests. All study drugs have known side effects, and some may be unknown. The study team will explain all known risks to you. You are free to withdraw from the study at any time without giving a reason, and it won't affect your future 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
Belgium

Common questions

What is the new drug BIA 28-6156 for?

This study isn't looking at what BIA 28-6156 treats, but rather how it behaves in the body and if it interacts with other common medicines. Its main purpose or condition it treats is not the focus here.

Will I get paid for taking part?

The study team will be able to tell you if there is any payment for your time and travel, as this can vary between studies. Please ask them directly.

What does a 'Phase 1' study mean?

Phase 1 is usually the first time a new medicine is tested in people. It mainly checks for safety and how the medicine is processed by the body, often in healthy volunteers.

Do I have to stop taking my usual medicines if I join?

The study team will review all your current medications. You may need to stop some, or certain medications might prevent you from joining the study. This will be discussed with you.

Will I know the results of the study?

Generally, study results are published after the research is complete. The research team might be able to tell you how to find out about the overall findings once they are available.