A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)
2 de septiembre de 2026 actualizado por: Merck Sharp & Dohme LLC
An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants
Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.
The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
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.
Ubicaciones de estudio
-
-
Florida
-
Daytona Beach, Florida, Estados Unidos, 32117
- Fortrea Clinical Research Unit Inc ( 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
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Be in good health
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Exclusion Criteria:
- Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m^2
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
- Has a history of cancer (malignancy)
- Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Part 1: MK-8527
Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
|
Tableta oral
|
|
Experimental: Part 2: MK-8527 + Probenecid
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.
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Tableta oral
Oral tablet
|
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Experimental: Part 3: MK-8527 + Itraconazole
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.
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Solucion Oral
Tableta oral
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Periodo de tiempo: Up to approximately 43 days
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who experience AE will be reported.
|
Up to approximately 43 days
|
|
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Periodo de tiempo: Up to approximately 43 days
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who discontinue study treatment due to an AE will be reported.
|
Up to approximately 43 days
|
|
Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: Tmax of MK-8527 in Plasma with and without Probenecid
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: Urine Concentration at 72 Hours of MK-8527
Periodo de tiempo: At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the urine concentration of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 2: Renal Clearance of MK-8527
Periodo de tiempo: At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the renal clearance of MK-8527.
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At designated timepoints (up to 72 hours postdose)
|
|
Part 2: Number of Participants Who Experience an AE
Periodo de tiempo: Up to approximately 43 days
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who experience AE will be reported.
|
Up to approximately 43 days
|
|
Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Periodo de tiempo: Up to approximately 43 days
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who discontinue study treatment due to an AE will be reported.
|
Up to approximately 43 days
|
|
Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole
Periodo de tiempo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Urine Concentration at 72 Hours of MK-8527
Periodo de tiempo: At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the urine concentration of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 3: Renal Clearance of MK-8527
Periodo de tiempo: At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the renal clearance of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 3: Number of Participants Who Experience an AE
Periodo de tiempo: Up to approximately 43 days
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who experience AE will be reported.
|
Up to approximately 43 days
|
|
Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE
Periodo de tiempo: Up to approximately 43 days
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who discontinue study treatment due to an AE will be reported.
|
Up to approximately 43 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
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)
30 de junio de 2026
Finalización primaria (Estimado)
9 de octubre de 2026
Finalización del estudio (Estimado)
9 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
16 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de junio de 2026
Publicado por primera vez (Actual)
22 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8527-021
- MK-8527-021 (Otro identificador: MSD)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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
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