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

NCT07672574 | Not Yet Recruiting Phase 1

• 1 other identifier: AGMB129-01-CL-105
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Absolute bioavailability of ontunisertib following oral and IV administration

  Part 1: To determine the absolute oral bioavailability of ontunisertib

  Through study completion, an average of 8 days

• Cumulative amount of total radioactivity excreted in urine and feces

  Part 2: To determine the mass balance recovery after a single oral dose of \[14C\]ontunisertib

  Through study completion, an average of 10 days

• Chemical structure of each metabolite accounting for ≥10% of circulating total radioactivity and Metabolite profiling accounting for >80% of total radioactivity recovered in urine and/or feces

  Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of \[14C\]ontunisertib

  Through study completion, an average of 10 days

Secondary Outcomes (10)

• PK parameter (AUClast)

  Through study completion, an average of 8 days

• Cumulative amount of total radioactivity excreted in urine and feces following IV administration

  Through study completion, an average of 8 days

• PK parameter (AUClast)

  Through study completion, an average of 18 days

• Whole blood-to-plasma concentration ratios for total radioactivity

  Through study completion, an average of 10 days

• Number of participants with adverse events (AEs)

  Through study completion, an average of 18 days

Study Arms (3)

Ontunisertib

EXPERIMENTAL

Participants will receive single oral dose of ontunisertib

Drug: Ontunisertib

[14C]ontunisertib solution for infusion

EXPERIMENTAL

Participants will receive single IV dose of \[14C\]ontunisertib

Drug: [14C]ontunisertib

[14C]ontunisertib

EXPERIMENTAL

Participants will receive single oral dose of \[14C\]ontunisertib

Drug: [14C]ontunisertib

Interventions

Ontunisertib DRUG

Oral capsule

Also known as: AGMB-129

Ontunisertib

[14C]ontunisertib DRUG

IV infusion

[14C]ontunisertib solution for infusion

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Only males are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agomab Spain S.L.U.: lead

Study Sites (1)

Quotient Sciences Limited

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Silke Hüttner, MD

  Agomab Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Agomab Clinical Operations

CONTACT

0032 3318 91 70; clinicalstudies@agomab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-Randomized, open-label, two-parts Phase I study

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 29, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)