Not yet recruitingPHASE1INTERVENTIONAL

A Study to Compare How CHF10196 (Florensocatib) is Absorbed Into the Blood When Given Alone and With a Drug That Reduces Stomach Acid in Healthy Male Participants

This research study is trying to understand how a new investigational medicine, Florensocatib (also known as CHF10196), is absorbed into the bloodstream. Specifically, we want to see if taking it at the same time as a medicine that reduces stomach acid (like Pantoprazole, which is often used for heartburn) changes how much of Florensocatib gets into a healthy person's system. We’ll be looking at healthy male volunteers who will take Florensocatib on its own, and then again with the stomach acid-reducing medicine. The aim is to make sure different medicines can be safely and effectively used together in the future. This is a very early-stage study, called Phase 1, typically done to check drug safety and how the body handles the medicine.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Chiesi Farmaceutici S.p.A.

Enrolment target

Start

14 Oct 2026

Estimated completion

09 Dec 2026

Healthy Volunteers

What is this study about?

This study is a Phase 1 clinical trial, which means it's an early-stage research study. The main goal of this particular study is to understand how a new medicine, called Florensocatib (you might also see it referred to as CHF10196), is absorbed into the body and how it behaves once it's there. Understanding this is really important for developing new medicines safely and effectively.

Specifically, researchers want to see if taking Florensocatib at the same time as another common medicine, Pantoprazole, changes anything. Pantoprazole is a type of drug often used to reduce stomach acid, for example, if someone has heartburn or indigestion. Sometimes, when you take two different medicines together, one can affect how the other one works or how much of it gets absorbed into your body. This is called a 'drug-drug interaction'.

By carefully studying healthy male volunteers, scientists can learn if taking Florensocatib with a stomach acid-reducing medicine changes how much Florensocatib gets into the bloodstream. This information is crucial for doctors to know how to prescribe medicines in the future, ensuring patients get the right dose and don't experience unexpected side effects when taking multiple medications.

Key takeaways

This study is looking at how a new medicine, Florensocatib, is handled by the body.
It aims to see if taking it with a stomach acid-reducing drug changes its absorption.
Only healthy men aged 18-55 will be taking part.
It's a Phase 1 study, focusing on early safety and how the drug moves through the body.
Participants will have regular health checks and blood tests.

Who may be eligible?

To join this study, you would need to be a healthy man aged between 18 and 55 years old. Your weight should be within a certain range for your height (this is measured using something called Body Mass Index or BMI). You should also be either a non-smoker or have stopped smoking a long time ago (meaning you've smoked less than 5 'pack-years' in total).

Before taking part, doctors will check your overall health through a medical history and examination, including checking your heart (with an ECG) and vital signs like blood pressure. You should not have any major health problems. You also need to be willing to use contraception during the study if required. If you've recently been part of another clinical study, or have certain infections like HIV or hepatitis, or have had recent COVID-19, you wouldn't be able to join. Also, if you've had surgery on your stomach or gut that might affect how medicines are absorbed, or if you're allergic to the study drugs, you wouldn't be eligible. They'll also check that you don't have any specific medical conditions or abnormal blood test results that might make the study unsafe for you.

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 a man aged between 18 and 55 years old?
Do you consider yourself generally healthy with no major long-term illnesses?
Do you not smoke, or did you stop smoking a long time ago (less than 5 pack-years)?
Are you able to attend study visits and follow instructions carefully?
Have you not taken part in another clinical study recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you are suitable. If you qualify, you will then come to the clinic for certain periods. During these times, you will receive the study medicines. You will take Florensocatib alone, and at another time, you will take Florensocatib along with Pantoprazole. Doctors and nurses will regularly take blood samples to measure how much of the medicines are in your system. They will also keep a close eye on you for any side effects and conduct health checks like measuring your heart rate and blood pressure.

They will also ask you to follow some specific instructions, for example, regarding what you eat or drink, or avoiding certain other medicines. There will be multiple visits over a period, including follow-up checks after you've finished taking the medicines. The total duration of your involvement, including all visits and follow-ups, would be explained to you in detail.

Potential risks and benefits

Participating in a clinical trial may not directly benefit you, but the information gained from this study could help future patients by providing important insights into how Florensocatib works. As with any medicine, there is a risk of side effects, which will be carefully monitored by the medical team. There's also the chance of discomfort from blood draws or other assessments. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Fortrea Clinical Research Unit (CRU) Limited
Verified postcode
Leeds, United Kingdom

Common questions

What is Florensocatib?

Florensocatib is a new medicine that is being studied. Its full purpose isn't revealed at this early stage, but this trial helps us understand how the body handles it.

What is Pantoprazole?

Pantoprazole is a common medicine that reduces the amount of acid in your stomach. It's often used to treat conditions like heartburn or acid reflux.

Why are you studying healthy men?

Early-stage studies often use healthy volunteers to understand how a new medicine behaves in a predictable way, without other illnesses or medications complicating the results. This helps establish a baseline.

What does 'Phase 1 study' mean?

Phase 1 studies are the first step in testing a new medicine in people. They mainly focus on safety and understanding how the medicine is absorbed, processed, and removed from the body.

Will I get paid for taking part?

The study information doesn't specify payment, but clinical trials often offer reimbursement for your time and travel. This would be fully explained before you agree to join.

How to find out more

Chiesi Clinical trial Info

clinicaltrials_info@chiesi.com +390521279715 Official trial record

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