A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)
2 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
44
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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Florida
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Daytona Beach, Florida, Estados Unidos, 32117
- Fortrea Clinical Research Unit Inc ( Site 0001)
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
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Comprimido oral
|
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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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Comprimido 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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Solução oral
Comprimido oral
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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.
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Predose and at designated timepoints (up to 336 hours postdose)
|
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Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food
Prazo: 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
Prazo: Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
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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
Prazo: 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.
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Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Prazo: 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.
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Up to approximately 43 days
|
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Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
|
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Part 2: Urine Concentration at 72 Hours of MK-8527
Prazo: At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the urine concentration of MK-8527.
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At designated timepoints (up to 72 hours postdose)
|
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Part 2: Renal Clearance of MK-8527
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de junho de 2026
Conclusão Primária (Estimado)
9 de outubro de 2026
Conclusão do estudo (Estimado)
9 de outubro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
16 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de junho de 2026
Primeira postagem (Real)
22 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 8527-021
- MK-8527-021 (Outro identificador: MSD)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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