Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An open, single arm, single-center, Phase 1 trial investigating the effect of 7-days-repeated administration of linaprazan glurate on the pharmacokinetics of repeated doses of an approved antibiotic in healthy participants

This is an early study, called a Phase 1 trial, looking into a new medication called linaprazan glurate. Researchers want to see how this new medicine interacts with a widely used antibiotic when healthy volunteers take both for seven days. The main goal is to understand if taking linaprazan glurate changes how the antibiotic works in the body. This kind of research is important because it helps scientists learn about potential interactions between medicines, ensuring they are safe and effective when used together. This information could be useful for treating conditions like stomach infections (Helicobacter pylori) or severe heartburn (GERD), where antibiotics and acid-reducing medicines are often prescribed together.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Cinclus Pharma Holding AB (publ)

Enrolment target

Start

21 Jan 2025

Helicobacter pylori infection GERD

What is this study about?

This study is an early investigation, sometimes called a Phase 1 trial. Think of it as a first step in testing a new medicine in people. The main aim here is to understand how a new medicine, called linaprazan glurate, behaves in your body when you also take a common antibiotic. Linaprazan glurate is designed to help reduce stomach acid, which can be useful for conditions like indigestion, ulcers caused by bacteria (Helicobacter pylori), or severe heartburn (GERD).

Researchers want to see if taking linaprazan glurate for seven days changes how the antibiotic is handled by your body. Does it make the antibiotic more or less effective? Does it change how quickly your body gets rid of the antibiotic? Understanding these interactions is very important for doctors to know if they can safely and effectively prescribe these medicines together.

This type of study is crucial because many people need to take different medicines at the same time. By carefully studying these interactions in healthy volunteers, scientists can gather important safety information before the medicines are given to patients who are unwell. It helps ensure that future treatments for conditions affecting the stomach are as safe and effective as possible.

Key takeaways

This is an early study testing how two medicines interact.
It aims to understand if a new stomach medicine affects an antibiotic.
The study involves healthy adult volunteers.
It helps scientists learn about potential drug interactions.
The findings could improve treatments for conditions like heartburn or stomach ulcers.

Who may be eligible?

This study is designed for healthy adults. To take part, you need to be at least 18 years old – there's no upper age limit, meaning older adults are welcome to participate too. This is because the study wants to see how the medicines interact in a healthy adult's body, without other health conditions complicating the results.

Both men and women are invited to take part in this research. The most important thing is that you are generally in good health.

Quick self-check

Are you 18 years old or older?
Are you generally healthy?
Are you able to visit a clinic several times?
Are you comfortable taking new medicines and having blood tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

As this is an early-stage study, it takes place at a single clinic. If you decide to take part, you would need to visit the clinic for several appointments over a short period. You would receive both the new medicine (linaprazan glurate) and an approved antibiotic, which you would take for seven days under close medical supervision. The research team would regularly check your health, take blood samples to measure how the medicines are working in your body, and ask you about any symptoms you might experience. The total duration of your active involvement in the study would likely be a couple of weeks, including follow-up checks after you stop taking the medicines.

Potential risks and benefits

Participating in research always involves some potential risks, such as side effects from the medicines or discomfort from blood tests. However, the study team will monitor you closely to ensure your safety. There are no direct personal benefits from participating in this particular study, as it's an early-stage trial in healthy people. However, you would be contributing valuable information that could help doctors safely treat stomach conditions like H. pylori infection or GERD for many others in the future. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Sweden

Common questions

What is linaprazan glurate?

It's a new medicine being tested to help reduce stomach acid, similar to medicines used for heartburn or stomach ulcers.

What does 'pharmacokinetics' mean?

It's a scientific term for how your body processes a medicine – how it's absorbed, distributed, changed, and removed from your body.

Why is this study only for healthy people?

Early studies like this are done in healthy people first to understand how the medicine works without other health problems confusing the results. This helps ensure it's safe before trying it in patients with illnesses.

Will I get paid for taking part?

Information about payment or compensation for your time and travel usually comes from the research clinic directly.

What is an 'approved antibiotic'?

This refers to a commonly used antibiotic that doctors already prescribe to treat various bacterial infections.