- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02998775
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
A Multicenter Phase 0 Study In Healthy Subjects and Subjects With Either Hepatic Or Renal Impairment To Obtain Plasma For Assessment In Vitro Lenvatinib Protein Binding
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. Approximately 6 participants with each degree (mild, moderate, or severe) of hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be enrolled. One cohort of healthy participants will be matched to the hepatic-impaired participants, whereas the other will be matched to the renal-impaired participants.
The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered in this study.
The end of the study will be the date of the last study visit for the last participant in the study.
The following estimates are provided:
- From first participant in to last participant out, the study is expected to take approximately one year to complete.
- The maximum estimated duration of the study for each participant is anticipated to be approximately 5 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Orlando, Florida, Estados Unidos
- Orlando Clinical Research Center, Inc.
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Minnesota
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Minneapolis, Minnesota, Estados Unidos
- DaVita Clinical Research
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Tennessee
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Knoxville, Tennessee, Estados Unidos
- New Orleans Center for Clinical Research
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Key Inclusion Criteria:
- Male or Female
Age, at the time of Informed Consent:
i. Hepatic Impairment Participants (Including Matched Healthy Participants): 18 to 70 years old, inclusive ii. Renal Impairment Participants (Including Matched Healthy Participants): 18 to 79 years old, inclusive
- Non-smokers and smokers who smoke no more than 10 cigarettes per day
- Besides diabetes and, as appropriate, renal or hepatic impairment, participants must have no history of acute or chronic clinically relevant disease or condition, as determined by the investigator.
For participants with hepatic impairment:
- Liver cirrhosis that has been stable;
- Platelet count >30,000 cells/millimeter cubed (mm^3);
- Total score on the Child-Pugh classification system between 5 and 6 (Group 1, mild), 7 and 9 (Group 2, moderate), and 10 and 15 (Group 3, severe)
For healthy participants:
• Creatinine clearance ≥ 81 milliliter per minute (mL/min)
For participants with renal impairment:
- Must have a diagnosis of renal impairment that has been stable
- Must have renal impairment in the following categories based on creatinine clearance values: mild (creatinine clearance, 50 to 80 mL/min), moderate (creatinine clearance, 30 to 49 mL/min), or severe (creatinine clearance, 15 to 29 mL/min) renal impairment
Exclusion Criteria:
Key Exclusion Criteria:
- Use of any new medication
- Human immunodeficiency virus (HIV) positive
- Presence of acute active liver disease or acute liver injury
- History of significant cardiovascular impairment
- Positive drug or alcohol test
- Weight loss or gain of >10% prior to Day 1
- Receipt of blood or blood products or donation of blood or blood products
For participants with hepatic impairment:
- History of hepatic transplant, systemic lupus erythematosus, or hepatic coma
- Received treatment with interferon or pegylated interferon
- Participants who have encephalopathy >Grade 2, sepsis, or gastrointestinal bleeding; esophageal varices >Grade 2, acute hepatic failure of any etiology, history of surgical portosystemic shunt, renal impairment (creatinine clearance <50 mL/min according to the Cockcroft-Gault formula), and rapidly deteriorating hepatic function
- Systolic blood pressure (SBP) ≥ 160 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) ≥ 100 mmHg
For healthy participants:
• Hemoglobin level less than 12.0 grams per deciliter (g/dL)
For participants with renal impairment:
- A history of renal transplant
- SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg for participants with mild renal impairment; SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg for participants with moderate and severe renal impairment
- Significant bleeding diathesis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: 6 participants with mild renal impairment
Renal Impairment Mild: creatinine clearance, 50 to 80 milliliters per minute (mL/min)
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Otro: 6 participants with moderate renal impairment
Renal Impairment Moderate: creatinine clearance, 30 to 49 mL/min
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Otro: 6 participants with severe renal impairment
Renal Impairment Severe: creatinine clearance, 15 to 29 mL/min
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Otro: 8 participants normal renal status
Renal status normal as defined by creatinine clearance ≥ 81 mL/min, otherwise age, gender, and smoking characteristics matching renal-impaired participants
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Otro: 6 participants with mild hepatic impairment
Hepatic impairment mild: total score on the Child-Pugh classification system between 5 and 6
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Otro: 6 participants with moderate hepatic impairment
Hepatic impairment moderate: total score on the Child-Pugh classification system between 7 and 9
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Otro: 6 participants with severe hepatic impairment
Hepatic impairment severe: total score on the Child-Pugh classification system between 10 and 15
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Otro: 8 participants normal hepatic status
Hepatic status normal, otherwise age, gender, and smoking characteristics matching hepatic-impaired participants
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of participants with any serious adverse event and any non-serious adverse event
Periodo de tiempo: 1 week
|
1 week
|
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 (Estimar)
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
- E7080-A001-010
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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