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RECRUITING
NCT07672574
PHASE1

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

Sponsor: Agomab Spain S.L.U.

View on ClinicalTrials.gov

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

Interventions

DRUG

Ontunisertib

Oral capsule

DRUG

[14C]ontunisertib

IV infusion

DRUG

[14C]ontunisertib

Oral capsule

Locations (1)

Quotient Sciences Limited

Nottingham, United Kingdom