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Radioactive tracer reveals how potential Crohn's drug moves through the body

NCT ID NCT07672574

Knowledge-focused Sponsor: Agomab Spain S.L.U. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This trial in 8 healthy men aged 30–65 examines how the body absorbs, breaks down, and eliminates ontunisertib, an experimental oral drug for fibrostenotic Crohn's disease. Participants receive a single dose of the drug with a radioactive label, allowing researchers to track its path and measure how much leaves the body through urine and stool. The goal is to understand the drug's metabolism and absolute bioavailability, which will guide future dosing in patient studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ontunisertib (AGMB-129)
What this could lead to
If successful, this could help determine the right dose of ontunisertib for future trials in people with fibrostenotic Crohn's disease.
What could go wrong
This is an early-phase study in only 8 healthy men, not patients. It focuses on drug processing, not on treating disease, so results may not predict effectiveness or safety in patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 65 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males aged 30 to 65 years inclusive at the time of signing informed consent * Must agree to the use of an adequate method of contraception for up to 93 days post-final dose * Healthy male participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities. * Body mass index of 18.0 to 29.9 kg/m2 Exclusion Criteria: * Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients * History of clinically significant renal, hepatic, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome, and neurological or psychiatric disorder * History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months) * Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator at screening. * Radiation exposure, including that from the present trial, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the trial * Participants who have been administered IMP in an ADME trial or any trial involving administration of 14C radioactivity in the last 12 months * Male participants with pregnant or lactating partners

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibrostenotic Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Quotient Sciences Limited

    RECRUITING

    Nottingham, NG11 6JS, United Kingdom

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