Fibrostenotic Crohn's DiseasePhase 1NCT07672574
Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
A Phase 1 study testing Ontunisertib and [14C]ontunisertib in people with Fibrostenotic Crohn's Disease, run by Agomab Spain S.L.U. at 1 site in United Kingdom.
Trial summary
This is an open, two-part study in healthy male volunteers, aged 30-65 years. This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine ([14C]ontunisertib) and determine the routes and rates of elimination of… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fibrostenotic Crohn's Disease
- What is being tested?
- Ontunisertib and [14C]ontunisertib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2026to 26 Sep 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Quotient Sciences Limited
Nottingham, NG11 6JS
About this study
Official title: An Open-label, Two-part Trial to Assess the Mass-balance Recovery, Metabolite Profile, Metabolite Identification and Absolute Bioavailability of [14C] Ontunisertib in Healthy Male Participants
This is an open, two-part study in healthy male volunteers, aged 30-65 years.
This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine ([14C]ontunisertib) and determine the routes and rates of elimination of the test medicine.
Read the detailed description
This is an open, two-part study in healthy male volunteers, aged 30-65 years with the trial duration of approximately 7 weeks.
In Part 1 of this study, healthy volunteers will be given a dose of test medicine orally followed by an intravenous injection of a very small dose of radiolabelled test medicine that contains a tiny amount of radioactivity (called carbon-14) so that the test medicine can be traced in the blood.
In Part 2, single doses of test medicine will be administered orally to find out how the body breaks down and gets rid of the test medicine. The test medicine will be 'radiolabelled' - it will contain a small amount of radioactivity (Carbon-14) - so that it can be traced in the body.
Participants will take part in both study parts and will remain resident in the clinic for up to 10 days after their final dose of Investigation Medicinal Product (IMP). After the participants have left the clinic, they may have to collect their urine and faeces at home until mass balance criteria has been met.
Over a period of at least 8 days in Part 1 and 10 days in Part 2, many blood samples will be taken, and volunteers will collect all their urine and faeces so that the amount of test medicine and its breakdown products can be measured/analysed.
A blood sample will be taken from volunteers between admission and first dose for pharmacogenetic testing.
- Conditions
- Fibrostenotic Crohn's Disease
- Being tested
- Ontunisertib, [14C]ontunisertib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OntunisertibDrug
Also called AGMB-129
Oral capsule
[14C]ontunisertibDrug
IV infusion
[14C]ontunisertibDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Ontunisertib | Experimental | Participants will receive single oral dose of ontunisertib Receives: Drug: Ontunisertib |
| [14C]ontunisertib solution for infusion | Experimental | Participants will receive single IV dose of [14C]ontunisertib Receives: Drug: [14C]ontunisertib |
| [14C]ontunisertib | Experimental | Participants will receive single oral dose of [14C]ontunisertib Receives: Drug: [14C]ontunisertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability of ontunisertib following oral and IV administration
Part 1: To determine the absolute oral bioavailability of ontunisertib
Measured: Through study completion, an average of 8 days
Cumulative amount of total radioactivity excreted in urine and feces
Part 2: To determine the mass balance recovery after a single oral dose of [14C]ontunisertib
Measured: Through study completion, an average of 10 days
Chemical structure of each metabolite accounting for ≥10% of circulating total radioactivity and Metabolite profiling accounting for >80% of total radioactivity recovered in urine and/or feces
Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of [14C]ontunisertib
Measured: Through study completion, an average of 10 days
Secondary outcomes (10)
PK parameter (AUClast)
Part 1: To characterize the IV PK (AUClast) of [14C]ontunisertib and total radioactivity in plasma
Measured: Through study completion, an average of 8 days
Cumulative amount of total radioactivity excreted in urine and feces following IV administration
Part 1: To determine the mass balance recovery after a single IV dose of [14C]ontunisertib
Measured: Through study completion, an average of 8 days
PK parameter (AUClast)
Part 1 and Part 2: To characterize the plasma PK (AUClast) of ontunisertib and metabolites and total radioactivity (Part 2 only) following a single oral dose
Measured: Through study completion, an average of 18 days
Whole blood-to-plasma concentration ratios for total radioactivity
Part 2: To evaluate the extent of distribution of total radioactivity into blood cells
Measured: Through study completion, an average of 10 days
Number of participants with adverse events (AEs)
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Measured: Through study completion, an average of 18 days
Number of participants with abnormal physical examinations
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Measured: Through study completion, an average of 18 days
Number of participants with abnormal vital signs
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Measured: Through study completion, an average of 18 days
Number of participants with abnormal ECGs parameters
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Measured: Through study completion, an average of 18 days
Number of participants with abnormal clinical laboratory safety tests
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Measured: Through study completion, an average of 18 days
Chemical structure analysis of metabolites accounting for ≥10%
Part 1: To characterize the metabolites profile in plasma following an IV dose of [14C]ontunisertib
Measured: Through study completion, an average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start9 Sep 2026
- Primary completion26 Sep 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrostenotic Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Non-Randomized, open-label, two-parts Phase I study
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agomab Spain S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silke Hüttner, MD, Study director, Agomab Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672574
- Sponsor's protocol ID
- AGMB129-01-CL-105
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No