CompletedPhase IInterventional

Human mass balance study of [14C]ontunisertib in healthy volunteers

This Phase I clinical trial is testing a new medicine called ontunisertib. It is being developed to treat a form of Crohn's disease that causes the bowel to narrow. Before testing it in patients, scientists need to understand how the human body processes the drug. The trial is open to healthy men aged 30 to 65. Participants will receive ontunisertib both as a capsule and as an injection. A tiny, safe amount of a radioactive tag (carbon-14) is added to the medicine so scientists can trace its journey through the bloodstream and measure how it leaves the body. Volunteers will need to stay overnight in a clinic for up to 10 days. During this time, the team will collect regular blood, urine, and stool samples. Taking part will not improve your health, but volunteers receive payment for their time and travel.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Agomab Spain, S.L.U.

Enrolment target

Start

24 Jun 2026

Estimated completion

26 Sep 2026

Fibrostenotic Crohn’s disease

What is this study about?

Crohn's disease is a lifelong condition that causes painful swelling and inflammation in the digestive system. In some people, this inflammation creates thick scar tissue that narrows the bowel, making it hard for food to pass through. Researchers are developing a new medicine called ontunisertib to help treat this narrowing.

Before a new drug can be given to patients, doctors must carry out Phase I trials in healthy volunteers. This study aims to find out how much medicine enters the bloodstream when swallowed as a capsule compared to an injection. It also looks at what the body breaks the medicine down into, and how quickly it is cleared out.

To track the drug, scientists attach a harmless 'tracer' with a tiny amount of radioactivity called carbon-14. This allows the research team to follow the medicine through the body and measure exactly how much passes out in urine and bowel movements. This information helps doctors work out safe and effective doses for future patient trials.

Key takeaways

Phase I study testing how the body breaks down a potential new Crohn's disease medicine.
Open to healthy men aged between 30 and 65 years.
Requires an overnight stay in a research clinic for up to 10 days.
Involves regular blood tests and collecting all urine and stool samples.
Uses a tiny, safe radioactive tracer to track the medicine through the body.
Volunteers receive payment for their time, travel, and clinic stay.

Who may be eligible?

This study is only open to healthy men between 30 and 65 years of age. Because it is an early safety trial, volunteers must have a healthy body weight (a BMI between 18.0 and 29.9) and pass full medical checks, including blood tests and heart tracings.

You cannot take part if you have a history of gut problems, such as Crohn's disease, irritable bowel syndrome (IBS), stomach ulcers, or major bowel surgery. People with significant heart, liver, or kidney problems, or those who have had high exposure to medical radiation in recent years, are also excluded.

Because the effects of this new medicine on unborn babies are unknown, you must agree to use reliable contraception during the trial and for about three months after your last dose. You cannot take part if your partner is currently pregnant or breastfeeding.

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.

I am a man aged between 30 and 65.
I am in good general health with no history of gut or bowel disorders.
My body mass index (BMI) is between 18.0 and 29.9.
I am willing and able to stay in a research clinic for up to 10 days.
I agree to use reliable contraception during the study and for 3 months afterwards.
My partner is not currently pregnant or breastfeeding.

Answer every question to see your result.

What does participation involve?

Taking part involves two study parts and requires staying at a specialist clinical unit for up to 10 days after your final dose. In Part 1, you will swallow a capsule of the study medicine and receive a tiny dose through a vein. In Part 2, you will swallow another single dose of the medicine.

During your stay, staff will monitor your health closely using blood tests, blood pressure checks, and heart scans (ECGs). You will also need to collect all of your urine and stool samples while in the clinic, and possibly for a few days at home, so the team can measure the medicine leaving your body. You will have to follow strict rules on food and drink, including short periods of fasting. The entire study takes place over several weeks between June and September 2026.

Potential risks and benefits

You will receive no direct medical benefit from joining this trial, but you will be helping to develop treatments for people living with Crohn's disease. You will receive financial compensation for your time, travel, and inconvenience. Risks include possible side effects from the study medicine, as well as bruising or temporary lightheadedness from regular blood tests. The amount of radiation used to track the medicine is very low—equal to about 17 days of normal background radiation in the UK—and carries negligible risk. Taking part is entirely voluntary, and you can change your mind and leave the trial at any time.

Locations (1)

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

Quotient Sciences Limited
City only
Nottingham, England

Common questions

Will taking part improve my health?

No. This trial is designed for healthy volunteers to study how the body handles the medicine. It provides no personal medical benefit.

Is the radiation used in this trial dangerous?

The amount of radiation is extremely small (about 0.125 mSv). This is roughly the same amount of natural background radiation you receive just living in the UK for 17 days, and it poses very little risk to your health.

Will I be paid for my time?

Yes. Volunteers receive payment to cover their committed time, travel expenses, and the inconvenience of staying in the clinic.

Why do I need to collect my urine and stool?

Scientists need to measure all the waste your body produces to see exactly how and when the medicine is cleared out of your system.

Can I leave the study early if I want to?

Yes. You have the right to withdraw from the trial at any point, without needing to give an explanation.

How to find out more

Clinical Operations, Agomab Spain, S.L.U.

clinicalstudies@agomab.com +32 33189170 Official trial record

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