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

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.

NCT Number	NCT07672574
Lead Sponsor	Agomab Spain S.L.U.
Conditions	Fibrostenotic Crohn's Disease
Enrollment	8 participants
Start Date	2026-07-20
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-29