Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Comparative Bioavailability of Cabozantinib Film-Coated Tablets in Healthy Participants Under Fasting Conditions

This early-stage study, known as a Phase I or 'Human Pharmacology' study, is investigating a medicine called cabozantinib. The main goal is to understand how well a new film-coated tablet version of cabozantinib is absorbed by the body compared to existing forms. This is called 'bioavailability'. We want to make sure the new tablet works in a similar way when taken without food. This kind of research helps ensure that new medicines, or new ways of taking them, are as effective and safe as possible. The study involves healthy adult volunteers to carefully monitor the medicine's behaviour in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bluepharma Industria Farmaceutica S.A.

Enrolment target

Start

13 Sep 2024

No medical condition.

What is this study about?

You might be wondering what this study is all about. It's an early-stage medical research study focusing on a medicine called cabozantinib. This particular study isn't about treating an illness, but rather understanding a new form of an existing medicine. Think of it like testing a new way to deliver a key ingredient in baking – you want to make sure it mixes in properly and tastes the same as before. In this case, researchers want to see if a new tablet version of cabozantinib is absorbed by the body in the same way as other forms of the medicine, specifically when taken on an empty stomach.

The main aim is to check something called 'bioavailability'. This simply means how much of the medicine gets into your bloodstream and how quickly it does so. Getting this right is really important because it helps doctors know that patients will get the right amount of medicine into their system, ensuring it can work as intended. This study is an important step in the development process for medicines, even though the medicine itself isn't being tested for treating a disease in this particular experiment.

Studies like this are vital for developing and improving medicines. By carefully studying healthy volunteers, researchers can gather important information about how the body handles the medicine without any other health conditions complicating the results. This foundational information helps ensure that when the medicine is eventually used to treat patients, it will be both effective and safe.

Key takeaways

This is an early-stage study (Phase I) checking how a new tablet form of cabozantinib is absorbed by the body.
It involves healthy adult volunteers, aged 18 and over, of any gender.
The main goal is to understand 'bioavailability' – how much medicine gets into your bloodstream.
Participants will take the medicine and have blood tests and other health checks.
This research helps ensure new medicine forms are effective and safe.
You can withdraw from the study at any time without penalty.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 years or older. There is no upper age limit, so as long as you are over 18, you can potentially take part. Both men and women are welcome to volunteer for this research.

Because this study is looking at how a medicine behaves in a healthy body, you must not have any major medical conditions. The research team will carry out checks to make sure you are in good general health before you can join.

More detailed information about specific health conditions or medications that might prevent you from joining would be provided directly by the study team if you express interest.

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?
Do you consider yourself generally healthy with no major long-term illnesses?
Are you able to follow specific instructions (like fasting) and attend all required study visits?
Are you interested in helping medical research without directly receiving treatment for an illness?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be helping researchers understand how the medicine cabozantinib is absorbed. Since this is an early-stage study, it usually involves staying at a special clinic for a period of time. You would be given the medicine (cabozantinib film-coated tablets) to take under specific conditions, most likely on an empty stomach, and your body's response would be closely monitored.

This monitoring typically involves having several blood samples taken over a set period to measure how much of the medicine is in your system. You might also have other check-ups like blood pressure readings and heart rate measurements. The total duration of your participation would involve a screening visit, one or more study periods where you receive the medication and are monitored, and potentially a follow-up call or visit. The exact number of visits, tests, and total time commitment would be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is contributing to important medical knowledge that could help improve medicines for future patients. You might also receive free health checks during the study. However, risks could include side effects from the study medicine, even though healthy volunteers are carefully monitored. The medicine might cause mild side effects like nausea or fatigue, or rarely, more serious ones. There are also discomforts associated with procedures like blood draws. You will be given a full explanation of all possible risks, and it's essential to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Portugal

Common questions

What is cabozantinib?

Cabozantinib is a medicine that is currently used to treat certain types of cancer. This study is not looking at it as a cancer treatment, but rather as a general test of how a new form of the medicine is absorbed.

Why do I need to be healthy to join?

This study needs healthy volunteers so that researchers can clearly see how the medicine works in the body without other illnesses or medications affecting the results. This helps them get a clear picture of the medicine itself.

What does 'bioavailability' mean?

Bioavailability simply refers to how much of the medicine gets into your bloodstream and how quickly your body absorbs it after you take it. It helps ensure the medicine can do its job properly.

Will I be given the actual medicine?

Yes, if you participate, you will be given the cabozantinib film-coated tablets to see how your body processes them. This is how the researchers measure its bioavailability.

What if I change my mind about taking part?

You are completely free to withdraw from the study at any point, for any reason, without needing to explain why. It will not affect your current or future medical care in any way.