- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07713758
A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney Function
A Phase 1, Open-label, Single-dose, Parallel-group Study Evaluating the Pharmacokinetics of Oral Repinatrabit (JNT-517) Immediate Release Tablet in Hepatic or Renal Impaired Adult Participants Matched to Adult Participants With Normal Hepatic and Renal Function
Descripción general del estudio
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Otsuka Call Center
- Número de teléfono: 844-687-8522
- Correo electrónico: Otsuka-ProfessionalServices@otsuka-us.com
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33014
- Reclutamiento
- Panax Clinical Research
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m^2) (inclusive).
- Able to provide written, informed consent.
- Male participants and female participants of childbearing potential (POCBP) must agree to remain fully abstinent from intercourse where pregnancy can occur OR practice 2 different contraceptive methods, where at least one must be highly effective.
- Otherwise be in generally good health.
Additional criteria for Group 1:
i. Have moderate hepatic impairment determined using Child-Pugh classification (Class B).
ii. Have relatively stable hepatic function for the duration of the study as determined by the investigator and liver function test at the time of screening or stable hepatic function 1 year prior to screening.
iii. Have normal renal function. iv. Have a clinical diagnosis of hepatic cirrhosis based on biopsy and/or clinical criteria.
Additional criteria for Group 2:
i. Have estimated glomerular filtration rate based on the Chronic Kidney Disease-Epidemiology Collaboration (eGFRCKD-EPI) lesser than (<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) indicating severe renal impairment.
ii. Not currently be on dialysis. iii. Have relatively stable renal function as determined by eGFRCKD-EPI. 7) Additional criteria for Group 3: i. eGFRCKD-EPI greater than or equal to (≥) 90 mL/min/1.73 m^2 indicating normal renal function.
ii. Have liver enzymes within normal limits.
Exclusion criteria:
- Participants who are breastfeeding.
- Participants who have a positive pregnancy test result prior to receiving the investigational medical product (IMP).
- Participants with international normalized ratio (INR) greater than (>) 2.3. Participants with hepatic impairment with elevated INR will be excluded based on the investigator's discretion.
- Participants with hepatic carcinoma or porto-hepatic shunts that have been surgically created or planted.
- A history of difficulty in obtaining intravenous access.
- The donation of blood or plasma > 250 milliliters (mL) within 30 days prior to screening or received > 50 mL of blood or plasma within 30 days prior to screening.
- Participants who have taken an investigational drug within 30 days prior to screening.
- Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (eg, occupational exposure to pesticides, organic solvents, etc).
- Any participant who, in the opinion of the investigator, should not participate in the trial.
- Previous exposure to repinatrabit.
- Additional criteria for Group 1: History of serious mental disorder including participants who have greater than Grade 1 encephalopathy as assessed by the Child-Pugh score and/or the investigator's judgment.
Additional criteria for Group 2:
i) Participants that have undergone a renal transplant. ii) Participants expected to require dialysis within 45 days. iii) Clinically significant abnormal findings in the serum chemistry, hematology, or urinalysis results obtained at screening or on Day -1, other than those associated with underlying renal conditions and other stable medical conditions consistent with the disease processes.
- Additional criteria for Group 3: History of or current hepatitis, or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HC).
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1: Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
|
Oral tablet
Otros nombres:
|
|
Experimental: Group 2: Severe Renal Impairment
Participants with severe renal impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
|
Oral tablet
Otros nombres:
|
|
Experimental: Group 3: Matched Normal Hepatic and Renal Function
Participants matched by age, weight, and sex with normal hepatic and renal function will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
|
Oral tablet
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve Calculated to the Last Observable Concentration at Time t (AUC0-t) of Repinatrabit
Periodo de tiempo: From Day 1 to Day 8
|
From Day 1 to Day 8
|
|
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit
Periodo de tiempo: From Day 1 to Day 8
|
From Day 1 to Day 8
|
|
Groups 1 and 2: Unbound and Total Maximum (Peak) Plasma Concentration (Cmax) of Repinatrabit
Periodo de tiempo: From Day 1 to Day 8
|
From Day 1 to Day 8
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
All Groups: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Severe Adverse Events (SAEs)
Periodo de tiempo: Up to Day 14
|
Up to Day 14
|
|
All Groups: Number of Participants With Potentially Clinically Relevant Clinical Laboratory Test Results
Periodo de tiempo: Up to Day 8
|
Up to Day 8
|
|
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs
Periodo de tiempo: Up to Day 8
|
Up to Day 8
|
|
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Physical Examination Findings
Periodo de tiempo: Up to Day 8
|
Up to Day 8
|
|
All Groups: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Results
Periodo de tiempo: Up to Day 8
|
Up to Day 8
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Metabolismo, errores congénitos
- Enfermedades Genéticas Congénitas
- Enfermedades metabólicas
- Enfermedades Cerebrales Metabólicas Congénitas
- Enfermedades Cerebrales Metabólicas
- Metabolismo de aminoácidos, errores congénitos
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades Nutricionales y Metabólicas
- Fenilcetonurias
Otros números de identificación del estudio
- 359-201-00009
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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.
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