Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An Open-Label, Fixed-Sequence, Drug-Drug Interaction Study in Healthy Participants to Evaluate the Effect of AGMB-129 on the Pharmacokinetics of Midazolam, a Sensitive Index Substrate of CYP3A4

This study aims to understand how a new investigational medicine, AGMB-129, affects the way the body handles another commonly used medicine called midazolam. Doctors call this a 'drug-drug interaction' study. In this specific study, healthy volunteers will take both medicines. Researchers will then check blood samples to see how much of midazolam (and a substance it turns into) is in the body and for how long. This helps determine if AGMB-129 changes how midazolam works. It's an early-stage study, meaning it's one of the first steps in testing a new medicine in people. This type of research is important to make sure new medicines are safe and work as expected when people might be taking other medications at the same time.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Agomab Spain S.L.

Enrolment target

Start

26 Jun 2023

Fibrostenotic Crohn’s disease

What is this study about?

This is an early research study, often called a Phase 1 study, looking into how a new medicine, AGMB-129, behaves in the body when taken alongside another medicine called midazolam. Midazolam is a commonly used medication, for example, to help with anxiety before medical procedures or for sedation. The main goal is to see if AGMB-129 changes how midazolam is processed and cleared from the body. Researchers will measure the levels of midazolam and what it breaks down into in the blood.

The study involves healthy volunteers, meaning people who don't have underlying health conditions. This allows researchers to focus specifically on the interaction between the two medicines without other health issues complicating the results. The new medicine, AGMB-129, is being developed for people with a condition called fibrostenotic Crohn’s disease, which is a type of inflammatory bowel disease where parts of the digestive system can narrow and block.

While this particular study doesn't involve people with Crohn's disease, understanding how AGMB-129 interacts with other common medicines is a crucial step before it can be widely used. Knowing these interactions helps make sure future patients with Crohn's disease can safely take AGMB-129 alongside any other medicines they might need.

Key takeaways

This is an early study to understand how two medicines interact in healthy volunteers.
It aims to see if a new medicine (AGMB-129) changes how midazolam is processed by the body.
The study involves healthy adults aged 18 and over, both men and women.
Participation includes taking study medicines and having regular blood tests and health checks.
The findings will help ensure future safe use of AGMB-129 for people with Crohn’s disease.
You can withdraw from the study at any time if you choose to.

Who may be eligible?

This study is looking for healthy adults. You must be at least 18 years old to take part, and there's no upper age limit mentioned.

Both men and women can join this study, as long as they meet all the other health and safety requirements.

Because this is a study looking at how medicines interact in generally healthy people, you would need to be in good overall health and not have any serious ongoing medical conditions. The study team will conduct health checks to make sure it's safe for you to participate.

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 with no serious existing medical conditions?
Are you comfortable with attending several clinic visits?
Are you able to provide regular blood samples?
Are you willing to avoid certain medications or foods during the study, if asked?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to visit the study clinic several times. You will be given doses of a medicine called BUCCOLAM (midazolam) and the investigational medicine, AGMB-129, in a set order. Researchers will take blood samples at specific times after you take the medicines to measure the levels of both midazolam and AGMB-129 in your blood. You'll also have regular health checks, including physical examinations, blood tests, and measurements of your vital signs like blood pressure and heart rate. Throughout the study, the team will closely monitor you for any side effects. The total duration of your involvement, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to medical knowledge, which could help people with fibrostenotic Crohn’s disease in the future. As a healthy volunteer, you might also receive close medical monitoring. Potential risks could include side effects from the study medicines, discomfort from blood draws, or potential drug interactions depending on your other medication use. You will be fully informed of all known potential risks before you consent to join. Remember, you have the right to withdraw from the study at any time and for any reason, without it affecting your usual 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 midazolam, and why is it used in this study?

Midazolam is a medicine that can cause sleepiness or reduce anxiety. It's used in this study to see how the new medicine, AGMB-129, affects how your body handles midazolam.

What is AGMB-129?

AGMB-129 is a new medicine being developed for people with a condition called fibrostenotic Crohn’s disease. This study is an early step in understanding how it works.

Will I get paid for taking part?

Some studies offer payment or reimbursement for time and travel. This information will be clearly explained by the study team if you are considered for participation.

What does 'pharmacokinetics' mean?

It's a fancy word for how your body processes a medicine – how it absorbs it, distributes it, breaks it down, and gets rid of it. This study is specifically looking at this for midazolam and AGMB-129.

Will my health information be kept private?

Yes, all your personal and medical information will be kept strictly confidential in line with privacy regulations.