A study to evaluate how well linaprazan glurate is absorbed and how it controls stomach acid (Part I) and investigation of the influence of a meal on the blood levels of linaprazan glurate (Part II) in healthy volunteers
Stomach acid helps us digest food, but having too much can cause painful conditions like acid reflux and heartburn. This early-stage study looks at a new drug called linaprazan glurate, designed to lower stomach acid levels. Because this is an early Phase 1 trial, doctors are testing it in healthy volunteers first. The trial has two main goals. First, doctors want to see how the drug is absorbed into the bloodstream and how effectively it controls acid in the stomach. Second, they want to find out whether taking the tablet with food affects how the body uses it. Participants will take the study medicine and have regular health checks, including blood tests. Taking part helps researchers understand if this treatment could safely help patients with acid-related stomach problems in the future.
At a glance
What is this study about?
Many people live with uncomfortable stomach conditions caused by excess stomach acid, such as acid reflux or stomach ulcers. While there are already treatments available, they do not work well for everyone. Researchers are developing a new medicine called linaprazan glurate to offer a potential new way to control stomach acid quickly and effectively.
Before a new medicine can be given to patients who are unwell, it must first be tested in healthy volunteers. This is called a Phase 1 clinical trial. Testing the drug in healthy people allows researchers to carefully study how the body handles the medicine without other health conditions confusing the results.
In this trial, the study team is exploring two key things. In the first part, they will measure how well the drug reduces acid in the stomach and how quickly it enters the bloodstream. In the second part, they will compare what happens when someone takes the tablet on an empty stomach versus taking it after a meal. This helps doctors decide the best way for future patients to take it.
By taking part, volunteers provide essential data that helps scientists determine if linaprazan glurate is safe, effective, and ready to move on to larger trials with patients in the future.
Key takeaways
- The study tests linaprazan glurate, a new medicine designed to reduce stomach acid.
- It is a Phase 1 study open to healthy volunteers aged 18 and older.
- Researchers want to see how the body absorbs the drug and whether food changes how it works.
- Participation involves health checks, blood tests, and short stays at a research clinic.
- Taking part does not provide direct health benefits, but it helps advance medical research.
Who may be eligible?
This study is looking for healthy adult men and women aged 18 and older. Because this is an early safety trial, volunteers need to be in generally good health with no ongoing serious illnesses.
You are unlikely to be eligible if you have a history of major stomach, heart, liver, or kidney problems, or if you regularly suffer from severe heartburn. The researchers also need to make sure you are not taking regular prescription medications that could interact with the study drug.
The study team will run several routine health checks, including blood tests and heart traces, to confirm whether taking part is safe for you before you can 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.
- I am aged 18 or older.
- I consider myself to be in good overall health.
- I do not have a chronic stomach or digestive illness.
- I am not currently taking regular prescription medicines.
- I am willing and able to stay overnight at a clinical research centre if required.
What does participation involve?
Taking part in this study involves visiting a specialist clinical trial unit. You may be asked to stay overnight for one or more short periods so the team can monitor you closely. During your stay, you will receive the study medicine, either on an empty stomach or after eating a standard meal.
Staff will carry out regular health checks, such as measuring your blood pressure, checking your heart rhythm, and taking blood and urine samples to see how much medicine is in your body. They may also monitor stomach acid levels. After you finish taking the medicine, there will be a final follow-up visit to make sure you are feeling well. The total time you are involved will usually range from a few weeks to a couple of months.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
Why is this medicine being tested on healthy people?
Testing new drugs in healthy volunteers first allows scientists to see how the human body processes the medicine without the influence of other illnesses or regular treatments.
Will I be paid for taking part?
Phase 1 trials for healthy volunteers typically provide compensation for your time, inconvenience, and travel expenses. The study team can give you the exact details.
Will I need to stay in the clinic overnight?
Yes, many Phase 1 trials require one or more overnight stays at the research clinic so doctors can take regular blood samples and monitor you closely.
What happens if I change my mind?
You are free to leave the trial at any point. Your decision will be respected, and the medical team will simply carry out a final check to ensure you are healthy.
Can I take my usual medicines during the study?
Most regular medicines, including over-the-counter painkillers or herbal supplements, are not permitted because they might interfere with the study results. Always tell the study team about anything you take.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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