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Clinical Trials in the UK / NCT07672574
Recruiting Phase 1

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

NCT07672574 · tracked via the Priya Life Science UK tracker
Sponsor
Agomab Spain S.L.U.
Phase
Phase 1
Started
2026-09-09
Last updated
2026-09-11

Condition(s) studied

Fibrostenotic Crohn's Disease

Investigational drug(s) / intervention(s)

Ontunisertib[14C]ontunisertib[14C]ontunisertib

Ontunisertib: Oral capsule

[14C]ontunisertib: IV infusion

[14C]ontunisertib: Oral capsule

Study 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 the test medicine.

Eligibility

Sex
MALE
Min age
30 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Quotient Sciences Limited Nottingham United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07672574 on ClinicalTrials.gov ↗ ← All trials in the UK