- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03346122
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
22 de enero de 2019 actualizado por: Janssen Research & Development, LLC
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
- Droga: JNJ-64991524 Dose Level 1
- Droga: Placebo
- Droga: JNJ-64991524 Dose Level 2
- Droga: JNJ-64991524 Dose Level 3
- Droga: JNJ-64991524 Dose Level 4
- Droga: JNJ-64991524 Dose Level 5
- Droga: JNJ-64991524 Dose Level 6
- Droga: JNJ-64991524 Dose Level 7
- Droga: JNJ-64991524 Dose Level 8
- Droga: JNJ-64991524 Dose Level 9
Tipo de estudio
Intervencionista
Inscripción (Actual)
86
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Antwerpen, Bélgica, 2060
- SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 60 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)^2 to 30 kg/m^2, inclusive, at screening
- Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
- Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
- Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
- A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -2
Exclusion Criteria:
- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
- History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
- Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Has a history of or is infected with human immunodeficiency virus (HIV [positive serology for HIV antibody]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) at screening
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1)
Participants will receive a single oral dose (Dose level 1) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
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Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
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Experimental: Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 2) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
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Experimental: Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 3) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
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Experimental: Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed)
Participants will receive a single oral dose (Dose level 4) of either JNJ-64991524 or placebo capsules in a fasted condition on Day 1 and fed condition, on Day 7.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
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Experimental: Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 5) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
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Experimental: Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 6) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
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Experimental: Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 7) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and pharmacokinetics (PK) from Part 1.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
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Experimental: Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 8) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
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Experimental: Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 9) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
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Experimental: Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 6) of JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined by tolerability and PK from Part 1.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability
Periodo de tiempo: Up to Day 20
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.
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Up to Day 20
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Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Periodo de tiempo: Up to Day 28
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
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Up to Day 28
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Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings
Periodo de tiempo: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
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Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Plasma Concentration of JNJ-64991524
Periodo de tiempo: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of JNJ-64991524.
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Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de noviembre de 2017
Finalización primaria (Actual)
20 de noviembre de 2018
Finalización del estudio (Actual)
20 de noviembre de 2018
Fechas de registro del estudio
Enviado por primera vez
15 de noviembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
15 de noviembre de 2017
Publicado por primera vez (Actual)
17 de noviembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
22 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CR108376
- 2017-000229-11 (Número EudraCT)
- 64991524EDI1001 (Otro identificador: Janssen Research & Development, LLC)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
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