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A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954

4 de septiembre de 2026 actualizado por: AstraZeneca

An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and Absolute Bioavailability of AZD4954 in Healthy Male Participants

This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.

This two-part study will take place at one site in Nottingham, United Kingdom, and will enroll 8 healthy men in each part, aged 30-65 years.

Descripción general del estudio

Descripción detallada

This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.

This study will take place at one site in Nottingham, United Kingdom.

It is planned to enroll 8 healthy male participants in each part, aged 30-65 years.

In part 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth. They'll stay in the clinic for up to 24 nights, attend 1 outpatient visit, and take up to 8 weeks to finish the study.

In part 2 volunteers will receive a single dose of test medicine by mouth and, shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein. They'll stay in the clinic for up to 15 nights, attend 1 outpatient visit, and take up to 7 weeks to finish the study.

Blood and urine samples will be collected to do safety tests. Blood, urine and faecal samples will be collected to measure the amount of test medicine and its breakdown products.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

16

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

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:

  • Healthy males aged 30 to 65 years inclusive
  • BMI of 18.0 to 35.0 kg/m2 inclusive
  • Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

Exclusion Criteria:

  • Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
  • Presence or history of clinically significant allergy requiring treatment
  • History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder
  • History of cholecystectomy or gall stones
  • History of GI surgery
  • Acute diarrhoea or constipation in the 7 days before the predicted Day 1
  • Participants who do not have suitable veins for multiple venepunctures/cannulation
  • Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
  • Evidence of renal impairment at screening
  • Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1
  • Participants who have previously been administered IMP in this study
  • Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
  • Participants who have been administered IMP in an ADME study in the last 12 months
  • Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
  • Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing
  • Current smokers or known or suspected history of alcohol or drug abuse
  • Excessive intake of caffeine-containing drinks or food

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: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Part 1
Participants in Part 1 will receive a single dose of [14C]AZD4954 Oral Solution.
Participants in Part 1 will recieve a single dose of [14C]AZD4954 oral solution
Experimental: Part 2
Participants in Part 2 will receive a single unlabelled oral dose of AZD4954 tablet and a radiolabelled IV microtracer dose of [14C]AZD4954.
Participants in Part 2 will receive a single dose of AZD4954 film-coated tablet by mouth
Participants in Part 2 will receive a single very tiny dose of radiolabelled [14C]AZD4954 Solution for Infusion as a slow injection into a vein

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Amount of AZD4954 excreted (Ae) (Part 1)
Periodo de tiempo: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Amount of AZD4954 excreted expressed as a fraction of dose excreted (Fe) (Part 1)
Periodo de tiempo: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Cumulative amount of AZD4954 excreted (CumAe) (Part 1)
Periodo de tiempo: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Cumulative amount of AZD4954 excreted expressed as a fraction of dose excreted (CumFe) (Part 1)
Periodo de tiempo: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Absolute bioavailability (F) based on AUC0-inf (Part 2)
Periodo de tiempo: Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
Absolute bioavailability of AZD4954 oral and IV administration, adjusted for dose
Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maximum observed concentration (Cmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Periodo de tiempo: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Time of maximum observed concentration (Tmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Periodo de tiempo: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4954 and total radioactivity (Parts 1 and 2)
Periodo de tiempo: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Terminal elimination half-life (T1/2) for AZD4954 and total radioactivity (Parts 1 and 2)
Periodo de tiempo: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Area under the curve (AUC) of circulating total radioactivity accounting for 10% or more of the dose (Part 1)
Periodo de tiempo: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Identification of the chemical structure of each metabolite
Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
80% or more of the radioactivity recovered in excreta (Part 1)
Periodo de tiempo: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Identification of the chemical structure of each metabolite
Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Disposition of total radioactivity in plasma and in blood (Part 1)
Periodo de tiempo: Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Quotient Sciences

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 (Estimado)

19 de octubre de 2026

Finalización primaria (Estimado)

17 de diciembre de 2026

Finalización del estudio (Estimado)

17 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

4 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • D7300C00005

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Marco de tiempo para compartir IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criterios de acceso compartido de IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

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. .

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