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

NCT07672574 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-09-04

No results posted yet for this 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.

Conditions

  • Fibrostenotic Crohn's Disease

Interventions

DRUG

Ontunisertib

Oral capsule

DRUG

[14C]ontunisertib

IV infusion

DRUG

[14C]ontunisertib

Oral capsule

Sponsors & Collaborators

  • Agomab Spain S.L.U.

    lead INDUSTRY

Principal Investigators

  • Silke Hüttner, MD · Agomab Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-09
Primary Completion
2026-09-26
Completion
2026-09-26

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672574 on ClinicalTrials.gov