Crohn'sRecruiting
Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
Phase 1 · Testing Ontunisertib and [14C]ontunisertib · 1 site · Agomab Spain S.L.U.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Ontunisertib (a drug), [14C]ontunisertib (a drug) and [14C]ontunisertib (a drug). Condition(s) listed: Fibrostenotic Crohn's Disease.
It is open-label: participants know what they are receiving.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 30 to 65
- Men only
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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…
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 8 participants are expected to take part.
- Start date: 2026-09-09.
- Main results expected around 2026-09-26 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- Absolute bioavailability of ontunisertib following oral and IV administration (Through study completion, an average of 8 days)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Fibrostenotic Crohn's Disease |
| Lead sponsor | Agomab Spain S.L.U. |
| Enrollment | 8 (estimated) |
| Start date | 2026-09-09 |
| Primary completion (est.) | 2026-09-26 |
| First posted | 2026-06-29 |
| Last updated | 2026-09-11 |
| 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 |
| ClinicalTrials.gov ID | NCT07672574 |
Interventions
- Ontunisertib (Drug)
Oral capsule - [14C]ontunisertib (Drug)
IV infusion - [14C]ontunisertib (Drug)
Oral capsule
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Quotient Sciences Limited | Nottingham | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.