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Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
Sponsor: Agomab Spain S.L.U.
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.
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
Key Details
Gender
MALE
Age Range
30 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2026-09-09
Completion Date
2026-09-26
Last Updated
2026-09-04
Healthy Volunteers
Yes
Conditions
Interventions
Ontunisertib
Oral capsule
[14C]ontunisertib
IV infusion
[14C]ontunisertib
Oral capsule
Locations (1)
Quotient Sciences Limited
Nottingham, United Kingdom