CompletedPhase IInterventional

A clinical trial to learn more about the absorption of radiolabeled drug LXE408, how the body breaks it down, and how quickly the body gets rid of it in healthy men

This study is testing a new medicine called LXE408, which is being developed to fight serious parasitic diseases such as Chagas disease and leishmaniasis. It's a very early-stage study, focusing on healthy men aged 30 to 55. The main goal is to understand exactly how the body handles this new medicine. Researchers want to know how much gets into the blood, how it's processed, and how quickly it leaves the body. This helps them work out the best way to use the medicine in the future. The study also checks for any side effects and how safe the medicine is. Participants will take a single dose and stay in a clinic for up to 10 nights, with some follow-up visits over several weeks.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Novartis Pharmaceuticals UK Limited

Enrolment target

Start

12 Jan 2026

Estimated completion

27 Mar 2026

Chagas disease, Visceral Leishmaniasis and Cutaneous Leishmaniasis.

What is this study about?

This research is looking into a new medicine, LXE408, which could help people suffering from diseases caused by parasites, such as Chagas disease and leishmaniasis. These illnesses can be very serious, and developing new treatments is really important.

Because this is a brand new medicine, it's crucial to understand how it works in the human body. This study, known as a Phase I trial, is designed for healthy volunteers. It allows researchers to carefully observe what happens when someone takes LXE408. They want to find out how much of the medicine gets into the bloodstream, how the body naturally breaks it down, and how quickly it's removed. This information is vital for deciding the right dose and how often it needs to be taken if the medicine proves effective in future studies.

Beyond understanding how the medicine moves through the body, a key part of this study is to check for safety. Researchers will be looking out for any side effects and making sure the medicine is well-tolerated. The information gathered from healthy volunteers in this early stage helps researchers make informed decisions for further development of LXE408, potentially bringing a new treatment option to patients in need.

Key takeaways

This study is testing a new medicine, LXE408, for parasitic diseases.
It's for healthy men, aged 30-55, to understand how the medicine works in the body.
You'll take one dose and have several clinic stays and follow-up visits over 11 weeks.
Your participation helps advance medical research, but offers no direct personal health benefit.
All risks will be explained, and you can withdraw at any time.

Who may be eligible?

This study is specifically looking for healthy men to take part, aged between 30 and 55 years old. To join, you'll need to be in good overall health, which means no significant medical problems and a healthy weight for your height.

There are also some specific health checks involved, like your blood pressure and heart rate needing to be within certain limits. You'll need to weigh at least 50 kg and have a Body Mass Index (BMI) between 18 and 30. You must also be able to swallow a standard capsule.

You won't be able to participate if you've recently taken part in another drug study, have strong allergies, or if the doctors think your veins aren't suitable for taking blood samples regularly.

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 between 30 and 55 years old?
Are you generally healthy, without any major medical conditions?
Do you have a healthy weight for your height (BMI between 18 and 30)?
Can you commit to attending clinic stays and follow-up visits for about 11 weeks?
Are you able to swallow a standard capsule?
Have you avoided other research studies involving new medicines within the last few months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given a single 300mg dose of the study medicine, LXE408, which contains a tiny amount of a special tracer (carbon-14) to help researchers track it in your body. You'll stay in the clinic for up to 10 nights for this part. After that, you'll have up to 5 additional outpatient visits, four of which will also involve an overnight stay at the clinic. The entire study will take about 11 weeks to complete.

Throughout the study, the research team will collect various samples, including blood, urine, and even stool and breath. These samples help them check your general health and safety, and also to measure how much of the medicine and its breakdown products are in your body.

Potential risks and benefits

As a healthy volunteer, you won't personally get any medical benefit from taking this experimental medicine. However, your participation is incredibly valuable as it helps researchers understand this new drug, which could eventually benefit many patients suffering from serious parasitic diseases. Like any medicine, there's always a chance of side effects, though the dose used is carefully considered, and you will be closely monitored by medical staff. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Quotient Sciences
Approximate
Nottingham, England

Common questions

What kind of diseases is LXE408 trying to treat?

LXE408 is being developed to treat parasitic diseases like Chagas disease and leishmaniasis.

Why is it important to use healthy volunteers for this study?

Using healthy volunteers helps researchers understand how the medicine works in the body without other health conditions or medications complicating the results. This is crucial for early-stage drug development.

Will I become radioactive from taking the medicine?

You will receive a single dose containing a tiny amount of 'tracer' carbon-14. This is a very small amount, similar to background radiation we all experience, and helps scientists track the medicine. It is not harmful.

How long will I be in the clinic?

You will have one stay of up to 10 nights, and then four more overnight stays during your outpatient visits. There will also be a few shorter outpatient visits.

Who is paying for this research?

The study is funded by Novartis Pharmaceuticals UK Limited.

How to find out more

Novartis Study Director

novartis.email@novartis.com +41 (0)61 324 11 11 Official trial record

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