- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04474210
A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants
An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-56136379 in Adult Participants
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Florida
-
Orlando, Florida, Estados Unidos, 32809
- Orlando Clinical Research Center
-
-
Texas
-
San Antonio, Texas, Estados Unidos, 78215
- The Texas Liver Institute
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Body mass index (BMI) (kilograms [kg]/height [m]^2) between 18.0 and 38.0 kilogram/meter^2 (kg/m2) (inclusive), and body weight not less than (<) 50 kg
Participants with normal renal function:
- Have normal renal function defined as estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter/minute computed with the online calculator on the CKD-EPI website by use of the Chronic Kidney Disease Epidemiology Collaboration creatinine clearance (CKD-EPIcr) result
- Must have stable renal function as defined as: (a) for participants with impaired renal function: <20 percent (%) change in serum creatinine concentrations between screening and Day -1; (b) for healthy participants: a change in serum creatinine concentration <0.2 milligram per deciliter (mg/dL) between screening and Day -1
Participants with renal impairment:
- Have an impaired renal function based on eGFR as(eGFR computed with the online calculator on the CKD-EPI website providing eGFR (in mL/min units) by use of the CKD-EPIcr result: (a) eGFR <90 to 60 mL/minute for participants in Group 3 (mild renal impairment cohort); (b) eGFR 30 to 59 mL/minute for participants in Group 4 (moderate renal impairment cohort); (c) eGFR <30 mL/minute but not yet on hemodialysis, for participants in Group 1 (severe renal impairment and/or kidney failure); (d) eGFR <15 mL/minute and on hemodialysis, for participants in Group 5 (kidney failure)
- Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 months (3 months for thyroid hormone replacement therapy [HRT]) before dosing as well as during the study
Exclusion Criteria:
- Individuals who take creatine supplements, have a non-standard muscle mass such as amputation, malnutrition, or muscle wasting; because these factors are not accounted for in the prediction equations for GFR chronic kidney disease epidemiology collaboration (CKD EPI)
Participants with normal renal function:
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day -1, as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, body temperature, or 12 lead ECG at screening or Day -1, as deemed appropriate by the investigator
Participants with renal impairment:
- Evidence of clinically apparent concurrent disease based upon complete clinical laboratory testing, full physical examination, or medical history, except for controlled hypertension and those problems directly associated with the primary diagnosis of renal impairment
- Any clinically significant laboratory abnormality except abnormalities that may be caused by renal impairment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Part A: Group 1
Participants with severe renal impairment and/or kidney failure (estimated glomerular filtration rate [eGFR] less than [<] 30 milliliter[mL]/minute but not yet on hemodialysis) will receive a single oral dose of JNJ-56136379.
|
Participants will receive JNJ-56136379 tablets orally.
|
|
Comparador Ativo: Part A: Group 2
Healthy participants with normal renal function (eGFR greater than or equal to [>=] 90 mL/minute), will receive a single oral dose of JNJ-56136379.
|
Participants will receive JNJ-56136379 tablets orally.
|
|
Experimental: Part B: Group 3 (Optional)
Participants with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.
|
Participants will receive JNJ-56136379 tablets orally.
|
|
Experimental: Part B: Group 4 (Optional)
Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.
|
Participants will receive JNJ-56136379 tablets orally.
|
|
Experimental: Part B: Group 5 (Optional)
Participants with kidney failure (eGFR: <15 mL/minute and on hemodialysis; pharmacokinetic [PK] to be evaluated during non-dialysis days) will receive a single oral dose of JNJ-56136379.
|
Participants will receive JNJ-56136379 tablets orally.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum Observed Plasma Analyte Concentration (Cmax)
Prazo: Up to Day 29
|
Cmax is defined as the maximum observed plasma analyte concentration.
|
Up to Day 29
|
|
Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)
Prazo: Up to Day 29
|
Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
|
Up to Day 29
|
|
Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])
Prazo: Up to 24 hours postdose
|
AUC (0-24) is defined as area under the analyte concentration-time curve (AUC) from time 0 to 24 hours postdose, calculated by linear-linear trapezoidal summation.
|
Up to 24 hours postdose
|
|
Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])
Prazo: Up to 144 hours postdose
|
AUC (0-144) is defined as AUC from time 0 to 144 hours postdose, calculated by linear-linear trapezoidal summation.
|
Up to 144 hours postdose
|
|
Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])
Prazo: Up to Day 29
|
AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
|
Up to Day 29
|
|
Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])
Prazo: Up to Day 29
|
AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.
|
Up to Day 29
|
|
Total Apparent Oral Clearance (CL/F)
Prazo: Up to Day 29
|
CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).
|
Up to Day 29
|
|
Apparent Volume of Distribution (Vd/F)
Prazo: Up to Day 29
|
Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].
|
Up to Day 29
|
|
Apparent Terminal Elimination Rate Constant (Lambda[z])
Prazo: Up to Day 29
|
Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve.
|
Up to Day 29
|
|
Apparent Terminal Elimination Half-life (t1/2)
Prazo: Up to Day 29
|
t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).
|
Up to Day 29
|
|
Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)
Prazo: Up to Day 7
|
Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100*(Aetotal/Dose).
|
Up to Day 7
|
|
Renal Clearance (CLr)
Prazo: Up to 144 hours postdose
|
CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).
|
Up to 144 hours postdose
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Número de participantes com eventos adversos como medida de segurança e tolerabilidade
Prazo: Até 8 semanas
|
Um EA é qualquer evento médico desfavorável que ocorre em um participante que administrou um produto experimental e não indica necessariamente apenas eventos com relação causal clara com o produto experimental relevante.
|
Até 8 semanas
|
Colaboradores e Investigadores
Patrocinador
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CR108802
- 56136379HPB1010 (Outro identificador: Janssen Research & Development, LLC)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .