Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn About if the Study Medicine Called Ibuzatrelvir changes how the body process the other Medicine Dabigatran Etexilate in healthy adults

This study is for healthy adults aged 18 and over, both men and women. It's designed to understand if a new medicine called Ibuzatrelvir changes how the body handles another medicine, Dabigatran Etexilate. Dabigatran Etexilate is often used to help prevent blood clots. Researchers want to ensure that if these two medicines are ever taken together, they work safely and as expected. This type of study, called a Phase I study, is an early step in testing new medications. It helps scientists learn important safety information and how medicines interact before they are given to many people. There isn't a specific condition being treated in this study; it's about understanding how medicines interact in healthy volunteers.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

19 Nov 2024

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

What is this study about?

This study is an early-stage research project looking into a new medicine called Ibuzatrelvir. The main goal is to find out if taking Ibuzatrelvir at the same time as another medicine, Dabigatran Etexilate, changes how Dabigatran Etexilate acts in the body. Dabigatran Etexilate is a medicine that's often prescribed to help prevent blood clots.

Medical scientists carry out these kinds of studies, called 'Phase I' studies, to gather important information about how new medicines work and interact. They do this in healthy volunteers first. It’s a bit like testing two different ingredients in a recipe to see if they affect each other. Understanding these interactions is crucial to make sure that if a new medicine like Ibuzatrelvir is ever widely used, it can be taken safely with other common medications.

This study isn't about treating a specific health problem. Instead, it's about learning fundamental information about how medicines behave when combined. This knowledge is really important for developing new treatments and making sure they are safe for everyone who might need them in the future. The information gathered will help doctors prescribe medicines more effectively and safely.

Key takeaways

Study examines how two medicines (Ibuzatrelvir and Dabigatran Etexilate) interact.
For healthy adults aged 18 and over, both men and women.
This is an early-stage (Phase I) study to gather safety information.
No treatment for a specific illness; focus is on drug interactions.
Participation involves clinic visits, taking study medicines, and health monitoring.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 or older. Both men and women can participate. The study is specifically looking for people who are generally well and don't have any major ongoing health problems.

Because the study is investigating how two medicines interact, you will need to meet certain health criteria to ensure it's safe for you to take the study medicines. This usually involves having normal blood test results and a healthy heart. Full details will be checked by the study team.

There may also be reasons why you *cannot* join the study, such as if you are taking certain other medications that could interfere, or if you have specific illnesses now or in the past. These details will be carefully explained to you by the study doctor.

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 in good health?
Are you comfortable taking a new study medicine?
Are you able to attend several clinic visits, possibly with overnight stays?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a health check to make sure you're suitable. This would involve a full medical history, blood tests, and other health assessments. If you qualify, you would then receive doses of both Ibuzatrelvir and Dabigatran Etexilate during the study.

The study would involve several visits to a clinic or hospital, during which you might need to stay overnight. During these visits, the study team would take regular blood samples to see how the medicines are being processed by your body. They would also monitor your general health very closely to make sure you are well and to check for any side effects.

After you have received the medicines, there will be follow-up appointments to ensure everything is okay. The exact number of visits, how long each visit lasts, and the total length of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study involves some potential risks, mainly from taking new medicines or having medical procedures like blood tests. You might experience side effects from the study medicines, which could range from mild to more serious, although serious side effects are rare. The study team will monitor you closely for any issues and will explain all known potential risks before you decide to join. While there's no direct health benefit to you as a participant since this study isn't treating a condition, the information gained will help improve medical knowledge and could benefit others in the future. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your 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 Ibuzatrelvir?

Ibuzatrelvir is a new medicine that is being studied. Researchers are trying to understand how it works and if it can be safely used with other medicines.

What is Dabigatran Etexilate used for?

Dabigatran Etexilate is a medicine that doctors prescribe to help prevent blood clots from forming in the body.

Will this study treat a health condition I have?

No, this study is about understanding how two medicines interact in healthy people, not about treating a specific disease or condition you might have.

What does 'Phase I' mean?

Phase I means it's an early stage of testing a new medicine, usually involving a small number of healthy volunteers, to learn about its safety and how it works in the body.

How long will I be involved in the study?

The exact duration of your involvement will be explained by the study team, as it can vary depending on the study's design and requirements for monitoring.