A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)
Healthy
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 1
- Rango de edad
- 19 años - 65 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 36 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
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.
Drug: MK-8507 · Drug: Islatravir
MK-8507 DRUG
Oral administration
Islatravir DRUG
Oral administration
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
Plazo: At designated timepoints (up to approximately 43 days)
Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite.
Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
Plazo: At designated timepoints (up to approximately 168 hours)
Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite.
Maximum Concentration (Cmax) of Islatravir Metabolite
Plazo: At designated timepoints (up to approximately 43 days)
Blood samples will be collected to determine Cmax of Islatravir metabolite.
Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
Plazo: At designated timepoints (up to approximately 168 hours)
Blood samples will be collected to determine the C168 of Islatravir metabolite.
Time to Maximum Concentration (Tmax) of Islatravir Metabolite
Plazo: At designated timepoints (up to approximately 43 days)
Blood samples will be collected to determine the Tmax of Islatravir metabolite.
Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
Plazo: At designated timepoints (up to approximately 43 days)
Blood samples will be collected to determine the t1/2 of Islatravir metabolite.
AUC0-Inf of Islatravir
Plazo: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the AUC0-Inf of Islatravir.
AUC0-168hrs of Islatravir
Plazo: At designated timepoints (up to approximately 7 days)
Blood samples will be collected to determine the AUC0-168hrs of Islatravir.
Cmax of Islatravir
Plazo: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine Cmax of Islatravir.
C168 of Islatravir
Plazo: At designated timepoints (up to approximately 168 hours)
Blood samples will be collected to determine the C168 of Islatravir.
Tmax of Islatravir
Plazo: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the Tmax of Islatravir.
t1/2 of Islatravir
Plazo: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the t1/2 of Islatravir.
Apparent clearance (CL/F) of Islatravir
Plazo: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the CL/F of Islatravir.
Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
Plazo: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the Vd/F of Islatravir.
AUC0-168hrs of MK-8507
Plazo: At designated timepoints (up to approximately 7 days)
Blood samples will be collected to determine the AUC0-168hrs of MK-8507.
Cmax of MK-8507
Plazo: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine Cmax of MK-8507.
C168 of MK-8507
Plazo: At designated timepoints (up to approximately 168 hours)
Blood samples will be collected to determine the C168 of MK-8507.
Tmax of MK-8507
Plazo: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine the Tmax of MK-8507.
t1/2 of MK-8507
Plazo: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine the t1/2 of MK-8507.
CL/F of MK-8507
Plazo: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine the CL/F of MK-8507.
Vd/F of MK-8507
Plazo: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine the Vd/F of MK-8507.
Medidas secundarias
Number of Participants Who Experience an Adverse Event (AE)
Plazo: 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.
Number of Participants Who Discontinue Study Treatment Due to an AE
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
Celerion (Site 0001)Lincoln, Nebraska, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Merck Sharp & Dohme LLC
- Inicio del estudio
- 17 ene 2024 Real
- Finalización primaria
- 23 jun 2024 Real
- Finalización del estudio
- 23 jun 2024 Real
- Primera publicación
- 1 oct 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
An Open-Label Study to Assess the Two-Way Interaction Between Multiple Weekly Doses of MK-8507 and Single Doses of Islatravir (MK-8591) in Healthy Adult Participants
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026