Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
10 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
8
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Agomab Clinical Operations
- Numero di telefono: 0032 3318 91 70
- Email: clinicalstudies@agomab.com
Luoghi di studio
-
-
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Nottingham, Regno Unito, NG11 6JS
- Reclutamento
- Quotient Sciences Limited
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Ontunisertib
Participants will receive single oral dose of ontunisertib
|
Oral capsule
Altri nomi:
|
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Sperimentale: [14C]ontunisertib solution for infusion
Participants will receive single IV dose of [14C]ontunisertib
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IV infusion
Oral capsule
|
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Sperimentale: [14C]ontunisertib
Participants will receive single oral dose of [14C]ontunisertib
|
IV infusion
Oral capsule
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Absolute bioavailability of ontunisertib following oral and IV administration
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
PK parameter (AUClast)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
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Whole blood-to-plasma concentration ratios for total radioactivity
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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%
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Silke Hüttner, MD, Agomab Therapeutics
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
9 settembre 2026
Completamento primario (Stimato)
26 settembre 2026
Completamento dello studio (Stimato)
26 settembre 2026
Date di iscrizione allo studio
Primo inviato
12 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 giugno 2026
Primo Inserito (Effettivo)
29 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- AGMB129-01-CL-105
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .