- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Orlando, Florida, Estados Unidos, 32809
- Orlando Clinical Research Center
-
-
Texas
-
San Antonio, Texas, Estados Unidos, 78215
- The Texas Liver Institute
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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 activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maximum Observed Plasma Analyte Concentration (Cmax)
Periodo de tiempo: 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)
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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])
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Número de participantes con eventos adversos como medida de seguridad y tolerabilidad
Periodo de tiempo: Hasta 8 semanas
|
Un AA es cualquier evento médico adverso que ocurre en un participante al que se le administra un producto en investigación, y no indica necesariamente solo eventos con una relación causal clara con el producto en investigación relevante.
|
Hasta 8 semanas
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR108802
- 56136379HPB1010 (Otro identificador: Janssen Research & Development, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Insuficiencia renal
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and Kidney... y otros colaboradoresReclutamientoEnfermedades Renales Crónicas | Fallo renal agudo | Lesión renal aguda | Insuficiencia Renal Aguda | Insuficiencia renal cronica | Insuficiencia Renal, Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia renal aguda | Insuficiencia Renal Crónica | Enfermedades... y otras condicionesEstados Unidos
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillTerminadoEnfermedades Renales Crónicas | Enfermedad Renal Crónica Etapa 5 | Enfermedad Renal Crónica etapa 4 | Enfermedad renal pediátrica | Enfermedad Renal Crónica etapa 3 | Enfermedad Renal Crónica Etapa V | Enfermedad renal crónica, estadio IV (grave) | Enfermedad Renal Crónica Etapa 2 | Enfermedad Renal...Estados Unidos
-
University Hospital, BordeauxMinistry of Health, FranceTerminadoTrasplante Renal | Enfermedad renal crónica en etapa terminal | Insuficiencia Renal Aguda SeveraFrancia
-
Faculdade de Ciências Médicas da Santa Casa de...TerminadoEnfermedad Renal Crónica | Diálisis renalBrasil
-
Wake Forest University Health SciencesStanford UniversityTerminadoTrasplante Renal | Rechazo Renal Agudo | Rechazo Renal Crónico | Rechazo de Trasplante Renal | Sistema Renina-AngiotensinaEstados Unidos
-
Outset MedicalTerminadoLesión renal aguda | Enfermedad renal en etapa terminal (ESRD) | Enfermedad renal en etapa terminal en diálisisEstados Unidos
-
Novartis PharmaceuticalsTerminadoHemodiálisis | Terapia de reemplazo renal | Enfermedad renal en etapa terminal (ESRD) | Trasplante Renal | Enfermedad renal crónica (ERC)Alemania, Estados Unidos, Bélgica, Italia, España, Croacia, Taiwán, Australia, Austria, Grecia, Corea, república de, Líbano, Chequia, Israel, Países Bajos, Eslovenia, Suiza, Tailandia, Noruega, Pavo, Suecia, Argentina, Brasil, Japón, Serbia, Federación Rusa y más
-
Vanessa Stadlbauer-Koellner, MDAustrian Science Fund (FWF)TerminadoFallo renal agudo | Insuficiencia renal cronicaAustria
-
European Society of Intensive Care MedicineTerminadoLesión renal aguda | Terapia de reemplazo renal | Enfermedad renal crónica en etapa terminalBélgica
-
Angiodynamics, Inc.TerminadoEnfermedad Renal Crónica | Lesión renal aguda | Fallo renal agudo | Insuficiencia renal crónica inducida por contrasteEstados Unidos
Ensayos clínicos sobre JNJ-56136379
-
Janssen Sciences Ireland UCTerminadoHepatitis B CrónicaBélgica, Estados Unidos, Japón, Corea, república de, Francia, Hong Kong, Canadá, Italia, Tailandia, Alemania, Malasia, España, Federación Rusa, Pavo, Reino Unido, Polonia, Brasil, Chequia, Porcelana
-
Janssen Research & Development, LLCTerminadoSaludableEstados Unidos
-
Janssen Sciences Ireland UCTerminadoHepatitis BEstados Unidos, Corea, república de, Francia, Bélgica, Italia, Taiwán, Reino Unido, Tailandia, Malasia, Porcelana, España, Canadá, Alemania, Japón, Federación Rusa, Pavo, Ucrania, Polonia, Hong Kong
-
Janssen Sciences Ireland UCTerminadoSaludable | Hepatitis CrónicaFrancia, Taiwán, España, Bélgica, Bulgaria, Malasia, Rumania, Alemania, Georgia, Moldavia, República de
-
Janssen Research & Development, LLCTerminado
-
Janssen Sciences Ireland UCTerminadoDeterioro hepáticoAlemania
-
Janssen Sciences Ireland UCTerminadoHepatitis B CrónicaBélgica, Reino Unido, Francia, Italia, Alemania, España, Polonia
-
Arrowhead PharmaceuticalsTerminadoHepatitis BAustralia, Hong Kong, Nueva Zelanda
-
Janssen Research & Development, LLCTerminadoHepatitis B CrónicaFrancia, Taiwán, Canadá, Estados Unidos, Alemania, España, Japón, Federación Rusa, Pavo, Reino Unido
-
Ottawa Hospital Research InstituteDesconocidoDisfunción de las glándulas de Meibomio | BlefaritisCanadá