Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A 3-Part Phase 1 Study to Investigate the Absolute Oral Bioavailability and Absorption, Metabolism, and Excretion of 14C-Unesbulin in Patients With Advanced Solid Tumor

This early-stage research study, called a Phase 1 trial, is looking at a new potential medicine named Unesbulin for people who have advanced solid tumours. The main goal is to understand how this medicine behaves in the body when taken by mouth. Scientists will be tracking a special version of Unesbulin (marked with a tiny amount of 14C, which is a safe tracer) to see how much of it the body absorbs, how it's processed, and how it eventually leaves the body. This information is crucial for developing the medicine further and understanding the best way to give it to patients. The study is open to adults aged 18 and over, of any gender.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

PTC Therapeutics Inc.

Enrolment target

Start

17 Apr 2023

Solid tumors

What is this study about?

This research is an early step in testing a new medicine called Unesbulin for people with advanced solid tumours. Advanced solid tumours are growths of abnormal cells that start in solid organs like the breast, lung, or bowel, and have spread to other parts of the body. This particular study is in an early stage, which means it’s one of the first times this medicine is being given to humans.

The main purpose of this study is not to see if the medicine works to shrink tumours yet, but rather to understand how it acts inside the body. Think of it like learning how a new car engine works: before you test how fast it can go, you need to know how much fuel it uses, how it processes that fuel, and what comes out the exhaust. Researchers will be giving a small, safe amount of a specially marked version of Unesbulin (with a tracer called 14C) to see exactly how much of it gets into the bloodstream, how the body processes it (this is called metabolism), and how it eventually leaves the body (this is called excretion).

Understanding these steps, known as 'bioavailability and absorption, metabolism, and excretion,' is really important. It helps scientists figure out the best way to give the medicine, for example, whether it should be taken with food, how often, and what dose might be most effective and safe in future studies. This information is a vital part of developing new medicines and making sure they can be given in the best possible way.

Key takeaways

This is an early-stage study (Phase 1) for a new oral medicine called Unesbulin.
It's for adults (18+) with advanced solid tumours, both men and women.
The main purpose is to understand how the body absorbs, processes, and gets rid of the medicine.
It uses a special marked version of the medicine to track its journey in the body.
The study helps guide future research into how this drug might best be used.
Participation involves taking the medicine and regular checks like blood and urine tests.

Who may be eligible?

This study is looking for adults who have been diagnosed with advanced solid tumours. Advanced means that the cancer has either spread or is no longer responding to standard treatments. Both men and women are welcome to take part in this study.

You must be at least 18 years old to be considered for this research. There isn't an upper age limit, meaning older adults can also participate as long as they meet the other health criteria.

Since this is an early-stage study, there will be very specific health requirements to make sure it's safe for people to take part. These details would be discussed with you by the study doctor, but generally, they look for people who are well enough to participate and don’t have other serious health problems that might make the new medicine unsafe for them.

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?
Have you been diagnosed with an advanced solid tumour?
Are you able to take medicines by mouth?
Are you well enough to participate in a research study?
You would need to discuss your full medical history with the study doctor.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have several visits to the study clinic or hospital. These visits would involve various checks and tests, such as blood samples, urine samples, and possibly scans, to monitor your health and see how your body is handling the study medicine. You would be given the study medicine, Unesbulin, which is taken by mouth.

Because this study is looking at how the body processes the medicine, there might be specific times you need to give samples after taking the dose. There will also be regular check-ups to monitor any side effects. After you finish taking the study medicine, there will be a follow-up period to ensure you are well and to collect any final information. The total duration of your involvement, including screening, treatment, and follow-up, would be fully explained to you by the study team.

Potential risks and benefits

Taking part in early-stage trials like this can offer potential benefits, such as access to a new medicine that isn't yet widely available, which might help your condition. However, there are also potential risks; new medicines can have side effects, some of which may be unknown or serious. The research team will carefully monitor you for any problems. You will be given full details of all known risks before you decide to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Hungary

Common questions

What does 'advanced solid tumour' mean?

It means the cancer started in a solid organ (like the breast, lung, or bowel) and has either spread to other parts of the body or is no longer responding to standard treatments.

What is a 'Phase 1' study?

It's an early study where a new medicine is given to people for the first time. The main goal is to check how safe it is and how the body handles it, not yet to see if it cures the disease.

What does '14C-Unesbulin' mean?

It means the medicine Unesbulin has been specially marked with a very tiny, safe amount of a tracer called 14C. This helps researchers track it precisely within your body.

Will this medicine cure my cancer?

This early-stage study is not designed to test if the medicine cures cancer. Its main aim is to understand how your body takes in and uses the medicine, which is an important step before testing if it can treat the disease.

Do I have to pay to join the study?

No, you should not have to pay to participate in a clinical trial. Any study-related care and medicines will be provided by the trial organisers.