Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
10 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
8
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Agomab Clinical Operations
- Número de teléfono: 0032 3318 91 70
- Correo electrónico: clinicalstudies@agomab.com
Ubicaciones de estudio
-
-
-
Nottingham, Reino Unido, NG11 6JS
- Reclutamiento
- Quotient Sciences Limited
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ontunisertib
Participants will receive single oral dose of ontunisertib
|
Oral capsule
Otros nombres:
|
|
Experimental: [14C]ontunisertib solution for infusion
Participants will receive single IV dose of [14C]ontunisertib
|
IV infusion
Oral capsule
|
|
Experimental: [14C]ontunisertib
Participants will receive single oral dose of [14C]ontunisertib
|
IV infusion
Oral capsule
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Absolute bioavailability of ontunisertib following oral and IV administration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PK parameter (AUClast)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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%
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Silke Hüttner, MD, Agomab Therapeutics
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de septiembre de 2026
Finalización primaria (Estimado)
26 de septiembre de 2026
Finalización del estudio (Estimado)
26 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2026
Publicado por primera vez (Actual)
29 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- AGMB129-01-CL-105
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .