Un estudio de MK-8507 e islatravir (MK-8591) en participantes adultos sanos (MK-8507-016)
Un estudio de etiqueta abierta para evaluar la interacción bidireccional entre múltiples dosis semanales de MK-8507 y dosis únicas de islatravir (MK-8591) en participantes adultos sanos
The main goals of this study are to learn what happens to Islatravir or MK-8507 in a person's body over time. Researchers will compare Islatravir given alone to Islatravir given with MK-8507. Researchers will also compare MK-8507 given alone to MK-8507 given with Islatravir.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Nebraska
-
Lincoln, Nebraska, Estados Unidos, 68502
- Celerion (Site 0001)
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
- 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 cancer with protocol specified exceptions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Islatravir+MK-8507
Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29. |
Oral administration Oral administration
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
Periodo de tiempo: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
Periodo de tiempo: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
|
|
Maximum Concentration (Cmax) of Islatravir Metabolite
Periodo de tiempo: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine Cmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
Periodo de tiempo: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
|
|
Time to Maximum Concentration (Tmax) of Islatravir Metabolite
Periodo de tiempo: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the Tmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
Periodo de tiempo: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the t1/2 of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
AUC0-Inf of Islatravir
Periodo de tiempo: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the AUC0-Inf of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
AUC0-168hrs of Islatravir
Periodo de tiempo: At designated timepoints (up to approximately 7 days)
|
Blood samples will be collected to determine the AUC0-168hrs of Islatravir. |
At designated timepoints (up to approximately 7 days)
|
|
Cmax of Islatravir
Periodo de tiempo: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine Cmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
C168 of Islatravir
Periodo de tiempo: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of Islatravir. |
At designated timepoints (up to approximately 168 hours)
|
|
Tmax of Islatravir
Periodo de tiempo: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the Tmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
t1/2 of Islatravir
Periodo de tiempo: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the t1/2 of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
Apparent clearance (CL/F) of Islatravir
Periodo de tiempo: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the CL/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
Periodo de tiempo: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the Vd/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
AUC0-168hrs of MK-8507
Periodo de tiempo: At designated timepoints (up to approximately 7 days)
|
Blood samples will be collected to determine the AUC0-168hrs of MK-8507. |
At designated timepoints (up to approximately 7 days)
|
|
Cmax of MK-8507
Periodo de tiempo: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine Cmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
C168 of MK-8507
Periodo de tiempo: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of MK-8507. |
At designated timepoints (up to approximately 168 hours)
|
|
Tmax of MK-8507
Periodo de tiempo: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the Tmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
t1/2 of MK-8507
Periodo de tiempo: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the t1/2 of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
CL/F of MK-8507
Periodo de tiempo: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the CL/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
Vd/F of MK-8507
Periodo de tiempo: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the Vd/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Periodo de tiempo: Up to approximately 5 months
|
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 an AE will be reported. |
Up to approximately 5 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Periodo de tiempo: Up to approximately 5 months
|
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 5 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8507-016
- MK-8507-016 (Otro identificador: MSD)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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. .