A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants
30 de septiembre de 2026 actualizado por: Bristol-Myers Squibb
A Phase 1, Open-label, Randomized, Pharmacokinetic Study to Assess the Drug Interactions and Food Effect of Navlimetostat (BMS-986504) in Healthy Female Participants
The purpose of this study is to assess the food effect and drug interactions on drug levels of Navlimetostat in health adult female participants
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
80
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: First line of the email MUST contain NCT # and Site #.
Copia de seguridad de contactos de estudio
- Nombre: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Número de teléfono: 855-907-3286
- Correo electrónico: Clinical.Trials@bms.com
Ubicaciones de estudio
-
-
Quebec
-
Québec, Quebec, Canadá, G1P 0A2
- Reclutamiento
- Syneos Health Clinique; Inc.
-
Contacto:
- Lidia Facchinelli, Site 0001
-
-
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
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria
- Participants must be healthy adult female (as assigned at birth) individuals not of childbearing potential (INOCBP) who have no clinically significant findings on medical history, physical examination (PE), vital signs (VS), 12-lead electrocardiograms (ECGs), or clinical laboratory determinations, as assessed by the investigator.
- Participants must have a BMI of 18.0 to 35.0 kg/m2, inclusive.
Exclusion Criteria
- Participants must not have any significant acute or chronic medical illness (in the assessment of the investigator).
- Participants must not have a history of prolonged bleeding or excessive bruising.
- Participants must not have any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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 Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Parte 2
|
Specified dose on specified days
Otros nombres:
Specified dose on specified days |
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Experimental: Parte 3
|
Specified dose on specified days
Otros nombres:
|
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Experimental: Parte 1A
|
Specified dose on specified days
Otros nombres:
Specified dose on specified days |
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Experimental: Parte 1B
|
Specified dose on specified days
Otros nombres:
Specified dose on specified days |
|
Experimental: Part 4
|
Specified dose on specified days
Otros nombres:
Specified dose on specified days |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Drug-related AEs
Periodo de tiempo: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
|
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Maximum observed concentration (Cmax) of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A, Part 1B, Part 3, Part 4 |
Up to approximately 3 weeks
|
|
Area under the concentration-time curve from time zero to 192 hours (AUC(0-192)) of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A |
Up to approximately 3 weeks
|
|
(AUC(INF)) of Navlimetostat with the coadministration of itraconazole
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A |
Up to approximately 3 weeks
|
|
AUC(INF) of Navlimetostat without the coadministration of itraconazole
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A |
Up to approximately 3 weeks
|
|
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1B, Part 3, Part 4 |
Up to approximately 3 weeks
|
|
AUC(INF) of Navlimetostat with the coadministration of Rifampin
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1B |
Up to approximately 3 weeks
|
|
AUC(INF) of Navlimetostat without the coadministration of Rifampin
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1B |
Up to approximately 3 weeks
|
|
Cmax of Midazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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AUC(0-T) of Midazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
|
AUC(INF) of Midazolam with the coadministration of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
|
AUC(INF) of Midazolam without the coadministration of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
|
AUC(INF) of Navlimetostat with a high fat meal
Periodo de tiempo: Up to approximately 3 weeks
|
Part 3 |
Up to approximately 3 weeks
|
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AUC(INF) of Navlimetostat without a high fat meal
Periodo de tiempo: Up to approximately 3 weeks
|
Part 3 |
Up to approximately 3 weeks
|
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AUC(INF) of Navlimetostat with the coadministration of Pantoprazole
Periodo de tiempo: Up to approximately 3 weeks
|
Part 4 |
Up to approximately 3 weeks
|
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AUC(INF) of Navlimetostat without the coadministration of Pantoprazole
Periodo de tiempo: Up to approximately 3 weeks
|
Part 4 |
Up to approximately 3 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adverse events (AEs)
Periodo de tiempo: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
|
|
Serious adverse events (SAEs)
Periodo de tiempo: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
|
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AEs leading to discontinuation of study or study intervention
Periodo de tiempo: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
|
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Number of participants with clinically significant changes in physical examination (PE)
Periodo de tiempo: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
|
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Number of participants with clinically significant changes in vital signs (VS)
Periodo de tiempo: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
|
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Number of participants with clinically significant changes in 12-lead electrocardiograms (ECGs)
Periodo de tiempo: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
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Number of participants with clinically significant changes in clinical laboratory test results
Periodo de tiempo: Up to approximately 6 weeks
|
Up to approximately 6 weeks
|
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Cmax of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Up to approximately 3 weeks
|
|
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AUC(0-T) of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Up to approximately 3 weeks
|
|
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AUC(INF) of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Up to approximately 3 weeks
|
|
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Tmax of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Up to approximately 3 weeks
|
|
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T-HALF of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Up to approximately 3 weeks
|
|
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Mean ratio (MR)_Cmax of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Up to approximately 3 weeks
|
|
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MR_AUC(0-T) of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Up to approximately 3 weeks
|
|
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MR_AUC(INF) of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Up to approximately 3 weeks
|
|
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AUC(0-T) of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A |
Up to approximately 3 weeks
|
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Time of maximum observed concentration (Tmax) of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A, Part 1B, Part 3, Part 4 |
Up to approximately 3 weeks
|
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Half-life (T-HALF) of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A, Part 1B, Part 3, Part 4 |
Up to approximately 3 weeks
|
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Apparent total body clearance (CLT/F) of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A, Part 1B, Part 3, Part 4 |
Up to approximately 3 weeks
|
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Apparent volume of distribution at terminal phase (Vz/F) of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A, Part 1B, Part 3, Part 4 |
Up to approximately 3 weeks
|
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Tmax of Midazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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T-HALF of Midazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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CLT/F of Midazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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Vz/F of Midazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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AUC(0-192) of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A |
Up to approximately 3 weeks
|
|
AUC(0-24) of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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MR_AUC(0-192) of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A |
Up to approximately 3 weeks
|
|
MR_AUC(0-24) of Navlimetostat Metabolite
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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Cmax of Rifampin
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A and Part 1B |
Up to approximately 3 weeks
|
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Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of Rifampin
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A and Part 1B |
Up to approximately 3 weeks
|
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Trough observed concentration (Ctrough) of Rifampin
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A and Part 1B |
Up to approximately 3 weeks
|
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Tmax of Rifampin
Periodo de tiempo: Up to approximately 3 weeks
|
Part 1A and Part 1B |
Up to approximately 3 weeks
|
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Cmax of 1-hydroxymidazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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AUC(0-T) of 1-hydroxymidazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
|
AUC(INF) of 1-hydroxymidazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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Tmax of 1-hydroxymidazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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T-HALF of 1-hydroxymidazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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MR_Cmax of 1-hydroxymidazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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MR_AUC(0-T) of 1-hydroxymidazolam
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
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MR_AUC(INF) of 1-hydroxymidazolam with the coadministration of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
|
MR_AUC(INF) of 1-hydroxymidazolam without the coadministration of Navlimetostat
Periodo de tiempo: Up to approximately 3 weeks
|
Part 2 |
Up to approximately 3 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Bristol-Myers Squibb, Bristol-Myers Squibb
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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)
31 de agosto de 2026
Finalización primaria (Estimado)
25 de marzo de 2027
Finalización del estudio (Estimado)
25 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
28 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de agosto de 2026
Publicado por primera vez (Actual)
2 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- 2-piridinilmetilsulfinilbenzimidazoles
- Sulfóxidos
- Compuestos de azufre
- Químicos orgánicos
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Benzimidazoles
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Azoles
- Compuestos policíclicos
- Benzazepines
- Compuestos heterocíclicos, 4 o más anillos
- Rifamycinas
- Lactamas, macrocíclicas
- Compuestos macrocíclicos
- Benzodiacepinas
- Triazoles
- Piperazines
- Pantoprazol
- Midazolam
- Rifampicina
- Itraconazol
Otros números de identificación del estudio
- CA240-0050
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Marco de tiempo para compartir IPD
See Plan Description
Criterios de acceso compartido de IPD
See Plan Description
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
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. .