A Study to Learn About the Study Medicine Called Prifetrastat in People With Renal Impairment
A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF PRIFETRASTAT IN PARTICIPANTS WITH MODERATE AND SEVERE RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL RENAL FUNCTION.
The primary purpose of this study is to understand how the body processes the study medicine, called prifetrastat, in people with renal impairment compared to healthy people with normal kidney function. Renal impairment means that a person has worse kidney function than normal. The study will also look at the safety and tolerability of prifetrastat in people with renal impairment compared to healthy people with normal kidney function.
This study is seeking participants who:
- Have moderate or severe renal impairment or
- Healthy people with normal kidney function
All participants in this study will receive a single dose of prifetrastat. The study medicine will be given by mouth at the study clinic. We will compare experiences of people with renal impairment and healthy people with normal kidney function.
Participants will take part in this study for about 2 months. During this time, they will stay at the study clinic for 8 to 16 days.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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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Florida
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Miami Lakes, Florida, Estados Unidos, 33016
- Floridian Clinical Research
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Tampa, Florida, Estados Unidos, 33603
- Genesis Clinical Research, LLC
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Minnesota
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Saint Paul, Minnesota, Estados Unidos, 55114
- Nucleus Network Minneapolis
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
- Female of nonchildbearing potential or males, 18 to 90 years of age at screening.
- Body mass index (BMI) of 16-40 kg/m2; and a total body weight >50 kg (110 lb).
- Stable renal function that matches the classification of either moderate renal impairment, severe renal impairment, or normal renal function.
Exclusion Criteria
- Any condition possibly affecting drug absorption
- Acute renal disease
- Renal allograft recipient
- Renal transplant recipient
- Urinary incontinence without catheterization
- Current use of any prohibited concomitant medication(s)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Moderate Renal Impairment (Cohort 1)
Prifetrastat administered by mouth as a single dose in participants with moderate renal impairment (eGFR = 30-59 mL/min). |
Prifetrastat administered by mouth as a single dose.
Otros nombres:
|
|
Experimental: Severe Renal Impairment (Cohort 2)
Prifetrastat administered by mouth as a single dose in participants with severe renal impairment (eGFR < 30 mL/min). |
Prifetrastat administered by mouth as a single dose.
Otros nombres:
|
|
Comparador activo: Normal Renal Function (Cohort 3)
Prifetrastat administered by mouth as a single dose in participants with normal renal function (eGFR ≥ 90 mL/min). |
Prifetrastat administered by mouth as a single dose.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prifetrastat
Periodo de tiempo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
|
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
|
|
Maximum Observed Plasma Concentration (Cmax) of Prifetrastat
Periodo de tiempo: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
|
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of Treatment-Emergent Adverse Events (AE) by Severity
Periodo de tiempo: From Baseline through follow-up, up to 35 days after last dose of study drug
|
From Baseline through follow-up, up to 35 days after last dose of study drug
|
|
Number of Participants With Clinically Significant Clinical Laboratories Abnormalities
Periodo de tiempo: From Baseline through follow-up, up to 35 days after last dose of study drug
|
From Baseline through follow-up, up to 35 days after last dose of study drug
|
|
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure or Heart Rate
Periodo de tiempo: From Baseline up to Day 16
|
From Baseline up to Day 16
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Number of Participants With Abnormalities in Physical Examination
Periodo de tiempo: From Baseline up to Day 16
|
From Baseline up to Day 16
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|
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Periodo de tiempo: From Baseline up to Day 16
|
From Baseline up to Day 16
|
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C4551013
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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