A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults
A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-07799544 USING A 14C-MICROTRACER APPROACH
For this study, the study medicine has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood, urine, and stool after it is given. This type of study is called a radiolabeled study.
The purpose of this radiolabeled study is to learn how a certain amount of [14C] PF-07799544 is taken up into the bloodstream and removed from the body.
The study is seeking participants who are:
Male Ages 18 to 55 years of age confirmed to be healthy based on medical and physical tests.
Weigh more than 50 kilograms (kg) and have a body mass index of 17.5 to 32 kg per meter squared.
The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-07799544 by mouth.
Part two will begin at least 14 days after the dose in part one. In part two, participants will receive one full dose of PF-07799544 by mouth and one small dose of [14C] PF-07799544 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.
To understand how the medicine is processed in the body, samples of blood, urine, feces, and vomit (if any) will be collected after each dose is given. This will help understand:
How much PF-07799544 is taken up into the bloodstream when taken by mouth compared to the dose given by IV How the body removes it from the blood steam. Participants will take part in the study for about 7 weeks, including evaluation at the start and follow-up period.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pfizer CT.gov Call Center
- Número de teléfono: 1-800-718-1021
- Correo electrónico: ClinicalTrials.gov_Inquiries@pfizer.com
Ubicaciones de estudio
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53704
- Reclutamiento
- Fortrea Clinical Research Unit Inc.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Males 18 to 55years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs.
BMI of 17.5-32 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
Total 14C radioactivity measured in plasma should not exceed 2.5 × standard biological carbon ratio.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cohort 1
Participants will receive one dose of [14C] PF-07799544 by mouth in Period 1.
After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of [14C] PF-07799544 in Period 2
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A single oral dose of [14C] PF-07799544 will be administered as an extemporaneous suspension in Period 1.
A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2.
A single IV infusion of [14C] PF-07799544 will be administered at the approximate Tmax after administration of the unlabeled oral dose of PF-07248144 in Period 2.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total recovery (%) of radioactivity in urine, feces and vomitus (if any), expressed as a percent of total oral radioactive dose administered.
Periodo de tiempo: Period 1 pre-dose to maximum days 15
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To characterize the extent of excretion of total radioactivity in urine, feces and vomitus (if any) following administration of a single oral dose of [14C]PF-07799544.
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Period 1 pre-dose to maximum days 15
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Metabolic profiling/identification and determination of relative abundance of [14C]PF-07799544 and the metabolites of PF-07799544 in plasma, urine and feces, if possible.
Periodo de tiempo: Period 1 pre-dose to maximum days 15
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To characterize the metabolic profile and identify the circulating and excreted metabolites of PF- 07799544 following administration of a single oral dose of [14C]PF-07799544.
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Period 1 pre-dose to maximum days 15
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The ratio of dose-normalized AUCinf (if data permit, otherwise AUClast) of oral PF-07799544 to IV [14C]PF-07799544.
Periodo de tiempo: Period 2 pre-dose to maximum days 6.
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To determine the oral absolute bioavailability (F) of PF-07799544 from a single oral dose of PF-07799544 compared to a single IV microtracer of [14C]PF-07799544.
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Period 2 pre-dose to maximum days 6.
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The ratio of total recovered radioactivity 14C in urine following single dose administration of [14C]PF-07799544 orally in Period 1 and IV microtracer, microdose administration of [14C]PF-07799544 in Period 2.
Periodo de tiempo: Period 1 pre-dose to maximum days 15; Period 2 pre-dose to maximum days 6.
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To determine the fraction of PF-07799544 dose absorbed (Fa) from a single oral dose of [14C]PF-07799544.
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Period 1 pre-dose to maximum days 15; Period 2 pre-dose to maximum days 6.
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Number of Participants With Treatment Emergent Adverse Events.
Periodo de tiempo: Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Number of Participants with Treatment Emergent Clinically Significant Laboratory Abnormalities.
Periodo de tiempo: Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Number of Participants With Treatment Emergent Clinically Significant Abnormal Vital Signs.
Periodo de tiempo: Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Number of Participants With Treatment Emergent Clinically Significant Physical Examination Abnormalities.
Periodo de tiempo: Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Number of Participants With Treatment Emergent Clinically Significant Abnormal ECG Measurements.
Periodo de tiempo: Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- C4901004
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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. .
Ensayos clínicos sobre Oral [14C] PF-07799544
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PfizerReclutamientoGlioma | Melanoma | Neoplasias Cerebrales | Cáncer de pulmón de células no pequeñas | Glioma de alto grado | Cáncer de tiroides | Tumores sólidos avanzados o metastásicos | Cáncer diferenciado de tiroides | Glioma de bajo grado | Neoplasmas malignos | NSCLC (cáncer de pulmón de células no pequeñas) | HGG | LggCanadá, Estados Unidos, Australia, Japón, Porcelana, Brasil, Israel
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