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A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)

2 de novembro de 2026 atualizado por: Merck Sharp & Dohme LLC

An Open-Label, Multiple-dose, Parallel Group Study to Evaluate the Pharmacokinetics of MK-6916 in Participants With Severe Renal Impairment and Moderate Renal Impairment

The purpose of this study is to learn what happens to MK-6916 in a person's body when given to participants with moderate or severe kidney impairment compared to healthy participants.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

32

Estágio

  • Fase 1

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

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Moderate and Severe Renal Impairment

  • Except for severe or moderate renal impairment, is sufficiently healthy for study participation
  • Has stable renal function Healthy
  • Matches mean age to participants with moderate and severe renal impairment

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

All participants

  • Has history of cancer (malignancy)
  • Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
  • Has had major surgery and/or donated or lost 1 unit of blood within 4 weeks prior to pretrial Participants with Renal Impairment
  • Has a history of renal artery stenosis, failed renal transplant or has had a nephrectomy, or end stage renal disease requiring dialysis

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: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Panel A: Severe Renal Impairment

Participants with severe renal impairment will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions.

Oral tablet

Experimental: Panel B: Moderate Renal Impairment

Participants with moderate renal impairment will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions.

Oral tablet

Experimental: Panel C: Healthy

Healthy participants will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions.

Oral tablet

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12) of MK-6916 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
AUC0-12 of MK-6916 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
Maximum Plasma Concentration (Cmax) of MK-6916 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Plasma Concentration at 12 Hours (C12) of MK-6916 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 on Day 16
Prazo: Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916.

Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of MK-6916 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Apparent Terminal Half-life (t1/2) of MK-6916 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Clearance at Steady State (CL,ss/F) of MK-6916 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the CL,ss/F of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Apparent Volume of Distribution at Steady State (Vz,ss/F) of MK-6916 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Vz,ss/F of MK-6916

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
AUC0-12 of MK-6916 Metabolite M5 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M5.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M9 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M9.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M10 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M10.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M5 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M9 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M10 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
Cmax of MK-6916 Metabolite M5 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M5.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M5 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M9 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M9.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M9 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M10 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M10.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M10 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
C12 of MK-6916 Metabolite M5 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M5.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M5 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M9 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M9.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M9 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M10 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M10.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M10 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
Tmax of MK-6916 Metabolite M5 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M5.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M5 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M9 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M9.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M9 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M10 on Day 1
Prazo: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M10.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M10 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M5 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M9 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M10 on Day 16
Prazo: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Number of Participants Who Experience an Adverse Event (AE)
Prazo: Up to approximately 75 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 an AE will be reported.

Up to approximately 75 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Prazo: Up to approximately 16 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 16 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.

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 (Estimado)

11 de dezembro de 2026

Conclusão Primária (Estimado)

6 de agosto de 2027

Conclusão do estudo (Estimado)

8 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

2 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de novembro de 2026

Primeira postagem (Real)

6 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 6916-013
  • MK-6916-013 (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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .