- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07812077
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954
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
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
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
¿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.
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Participants in Part 1 will recieve a single dose of [14C]AZD4954 oral solution
|
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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.
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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
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¿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
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Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
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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
|
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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
|
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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
|
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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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Quotient Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
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)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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