Not yet recruitingPHASE1INTERVENTIONAL

Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers

This study is for healthy men aged 30 to 65 and focuses on a new medicine called Ontunisertib, which is being investigated for a gut condition known as Fibrostenotic Crohn's Disease. It's a 'Phase 1' study, meaning it's one of the first human trials. The main goal is to understand how the human body handles Ontunisertib. Researchers will give a single dose of the medicine, which will have a tiny amount of radioactivity (carbon-14) added to it. This tiny 'tag' helps them track how the medicine is absorbed, spread around the body, broken down, and finally, how it leaves the body. By tracking the medicine in blood, urine, and faeces, they can learn how quickly and through which routes it's eliminated.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Agomab Spain S.L.U.

Enrolment target

Start

20 Jul 2026

Estimated completion

31 Dec 2026

Fibrostenotic Crohn's Disease

What is this study about?

This study is looking into a potential new medicine called Ontunisertib, which is being developed to help people with a specific type of Crohn's Disease called Fibrostenotic Crohn's Disease. Crohn's Disease is a long-term condition that causes inflammation in the digestive system. This particular study is an early-stage trial, referred to as a 'Phase 1' study. At this stage, the main focus isn't on treating the illness, but on understanding how the medicine behaves in the human body.

The researchers want to find out exactly what happens to Ontunisertib once someone takes it. This includes how much of it the body absorbs, where it goes once it's in the body, how the body breaks it down (metabolises it), and how it eventually leaves the body (is eliminated). To do this, they will use a special version of the medicine that has a tiny, safe amount of a radioactive 'tag' called Carbon-14. This tag allows them to track the medicine's journey through the body using blood, urine, and stool samples. This information is really important because it helps scientists work out the right dose and how often the medicine might need to be taken in future studies.

By gathering this detailed information from healthy volunteers, the researchers can build a complete picture of how Ontunisertib interacts with the human body. This understanding is a crucial step before the medicine can be tested in patients who have Crohn's Disease. It helps ensure that when it does go into further trials, they have a better idea of how the body will react to it, making future patient studies safer and more effective.

Key takeaways

Study for healthy men aged 30-65 years.
Investigates a new medicine, Ontunisertib, for Crohn's Disease.
Aims to understand how the body handles the medicine using a special 'tag'.
Involves clinic stays, blood tests, and collecting urine/faeces.
Total study duration is about 7 weeks.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You would need to be between 30 and 65 years old at the time you agree to take part.

To be considered, you'll need to be in good overall health. A doctor will check this with a full health review, including a physical exam, heart check (ECG), and blood tests. Your body mass index (BMI) should be between 18.0 and 29.9 kg/m2, which is generally considered a healthy weight range.

There are also reasons why you wouldn't be able to join. For example, if you've had a bad reaction to medicines in the past, or if you have certain serious health conditions affecting your kidneys, liver, lungs, or gut – especially if you have Crohn's Disease, ulcerative colitis, or irritable bowel syndrome. You also can't have had major stomach surgery recently (unless it was for appendicitis or a hernia more than a year ago). If you have a partner who is pregnant or breastfeeding, you would also not be able to participate. They also need to make sure you haven't recently been part of another study involving radioactivity.

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 male between 30 and 65 years old?
Are you generally healthy with no serious long-term illnesses?
Do you have a healthy weight for your height (BMI between 18.0 and 29.9)?
Are you willing to use contraception for a few months after the study?
Have you avoided other research studies involving radioactivity recently?
Do you not have partners who are pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 7 weeks in total. It's split into two parts. You'll need to stay at the clinic for up to 10 days after your last dose of the study medicine. In Part 1, you'll first take a dose of the medicine by mouth. Then, you'll also receive a very small injection into a vein of the same medicine, but this version will contain a tiny amount of the 'tag' (carbon-14) to help researchers track it. In Part 2, you'll only take a single dose of the tagged medicine by mouth.

Throughout these periods, the research team will take many blood samples – especially during the at least 8 days in Part 1 and 10 days in Part 2. You will also be asked to collect all your urine and faeces. This is so the researchers can measure how much of the medicine and its breakdown products are leaving your body. You'll have a blood sample taken at the very beginning for genetic testing. After you leave the clinic, you might need to continue collecting your urine and faeces at home until enough samples have been gathered. You must agree to use effective contraception for up to 93 days after your last dose of the study medicine.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research and helping doctors understand new medicines that could eventually help people with Crohn's Disease. You will also receive careful medical monitoring during the study. Potential risks include discomfort from blood samples, staying in the clinic, and potential side effects from the study medicine, although this is an early-stage study in healthy volunteers. While the amount of radioactivity used is very small and carefully controlled to be safe, there's always an extremely low, theoretical risk associated with any radiation exposure. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Quotient Sciences Limited
Verified postcode
Nottingham, United Kingdom

Common questions

What is Ontunisertib?

It's a new medicine being studied for a type of Crohn's Disease, but this study won't measure if it treats the condition itself.

Why is it called a 'mass balance' study?

This means the researchers want to account for the 'mass' of the medicine by tracking how much goes into, through, and out of your body.

What is 'Carbon-14' and is it safe?

Carbon-14 is a tiny, safe amount of radioactivity added to the medicine to help researchers track it in your body. The amount used is very small and controlled.

Will I have to stay in the clinic?

Yes, you will need to stay in the clinic for up to 10 days after your last dose of the medicine in each part of the study.

Do I need to be healthy to join?

Yes, this study is only for healthy male volunteers. You'll have a full health check to make sure you're suitable.

How to find out more

Agomab Clinical Operations

clinicalstudies@agomab.com 0032 3318 91 70 Official trial record

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