Um estudo de MK-8507 e Islatravir (MK-8591) em participantes adultos saudáveis (MK-8507-016)
Um estudo aberto para avaliar a interação bidirecional entre múltiplas doses semanais de MK-8507 e doses únicas de islatravir (MK-8591) em participantes adultos saudáveis
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68502
- Celerion (Site 0001)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
Outros nomes:
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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 Infinity (AUC0-Inf) of Islatravir Metabolite
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Prazo: 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
Prazo: 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
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 8507-016
- MK-8507-016 (Outro identificador: MSD)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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