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

10 september 2026 bijgewerkt door: Agomab Spain S.L.U.

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is an open, two-part study in healthy male volunteers, aged 30-65 years with the trial duration of approximately 7 weeks.

In Part 1 of this study, healthy volunteers will be given a dose of test medicine orally followed by an intravenous injection of a very small dose of radiolabelled test medicine that contains a tiny amount of radioactivity (called carbon-14) so that the test medicine can be traced in the blood.

In Part 2, single doses of test medicine will be administered orally to find out how the body breaks down and gets rid of the test medicine. The test medicine will be 'radiolabelled' - it will contain a small amount of radioactivity (Carbon-14) - so that it can be traced in the body.

Participants will take part in both study parts and will remain resident in the clinic for up to 10 days after their final dose of Investigation Medicinal Product (IMP). After the participants have left the clinic, they may have to collect their urine and faeces at home until mass balance criteria has been met.

Over a period of at least 8 days in Part 1 and 10 days in Part 2, many blood samples will be taken, and volunteers will collect all their urine and faeces so that the amount of test medicine and its breakdown products can be measured/analysed.

A blood sample will be taken from volunteers between admission and first dose for pharmacogenetic testing.

Studietype

Ingrijpend

Inschrijving (Geschat)

8

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigd Koninkrijk
      • Nottingham, Verenigd Koninkrijk, NG11 6JS
        • Werving
        • Quotient Sciences Limited

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ontunisertib
Participants will receive single oral dose of ontunisertib
Geneesmiddel: Ontunisertib
Oral capsule
Andere namen:
  • AGMB-129
Experimenteel: [14C]ontunisertib solution for infusion
Participants will receive single IV dose of [14C]ontunisertib
Geneesmiddel: [14C]ontunisertib
IV infusion
Geneesmiddel: [14C]ontunisertib
Oral capsule
Experimenteel: [14C]ontunisertib
Participants will receive single oral dose of [14C]ontunisertib
Geneesmiddel: [14C]ontunisertib
IV infusion
Geneesmiddel: [14C]ontunisertib
Oral capsule

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Absolute bioavailability of ontunisertib following oral and IV administration
Tijdsspanne: Through study completion, an average of 8 days
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
Tijdsspanne: Through study completion, an average of 10 days
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
Tijdsspanne: Through study completion, an average of 10 days
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PK parameter (AUClast)
Tijdsspanne: Through study completion, an average of 8 days
Part 1: To characterize the IV PK (AUClast) of [14C]ontunisertib and total radioactivity in plasma
Through study completion, an average of 8 days
Cumulative amount of total radioactivity excreted in urine and feces following IV administration
Tijdsspanne: Through study completion, an average of 8 days
Part 1: To determine the mass balance recovery after a single IV dose of [14C]ontunisertib
Through study completion, an average of 8 days
PK parameter (AUClast)
Tijdsspanne: Through study completion, an average of 18 days
Part 1 and Part 2: To characterize the plasma PK (AUClast) of ontunisertib and metabolites and total radioactivity (Part 2 only) following a single oral dose
Through study completion, an average of 18 days
Whole blood-to-plasma concentration ratios for total radioactivity
Tijdsspanne: Through study completion, an average of 10 days
Part 2: To evaluate the extent of distribution of total radioactivity into blood cells
Through study completion, an average of 10 days
Number of participants with adverse events (AEs)
Tijdsspanne: Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Number of participants with abnormal physical examinations
Tijdsspanne: Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Number of participants with abnormal vital signs
Tijdsspanne: Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Number of participants with abnormal ECGs parameters
Tijdsspanne: Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Number of participants with abnormal clinical laboratory safety tests
Tijdsspanne: Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Chemical structure analysis of metabolites accounting for ≥10%
Tijdsspanne: Through study completion, an average of 8 days
Part 1: To characterize the metabolites profile in plasma following an IV dose of [14C]ontunisertib
Through study completion, an average of 8 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Agomab Spain S.L.U.

Onderzoekers

  • Studie directeur: Silke Hüttner, MD, Agomab Therapeutics

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 september 2026

Primaire voltooiing (Geschat)

26 september 2026

Studie voltooiing (Geschat)

26 september 2026

Studieregistratiedata

Eerst ingediend

12 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2026

Eerst geplaatst (Werkelijk)

29 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 september 2026

Laatste update ingediend die voldeed aan QC-criteria

10 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • AGMB129-01-CL-105

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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