Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Participants
5 de diciembre de 2016 actualizado por: Janssen Research & Development, LLC
A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-55375515 in healthy participants after administration of single and multiple oral doses.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized (study medication assigned to participants by chance), double-blind (neither the investigator nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive comparator treatment that has no study drug in it), single center study in healthy male participants and female participants of non-childbearing potential (surgically sterile or post menopausal), aged 18 to 58 years inclusive.
This study will consist of two parts; a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part.
The SAD will consist of 6 escalating dose cohorts.
Participants in each cohort will be randomized to receive a single oral administration of JNJ-55375515 or placebo after an overnight fast.
The planned doses of JNJ-55375515 range from 0.75 to 100 milligrams (mg).
Participants in an additional cohort will be dosed in the fed state to determine the effects of food on the safety, tolerability and pharmacokinetics of JNJ-55375515.
An additional optional cohort may be evaluated to further explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-55375515, with the maximal dose not exceeding 200 mg.
The study duration for participants in the SAD part of the study will be approximately 2 to 5.5 weeks, including eligibility Screening.
The MAD will consist of 3 cohorts of 9 participants.
Participants will receive once daily oral doses of JNJ-55375515 or placebo for 10 consecutive days.
The study duration for participants in the MAD part of this study will be approximately 3 to 7 weeks including the eligibility Screening.
The Safety of Participants will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
175
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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Merksem, Bélgica
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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 58 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participant must be healthy on the basis of physical and neurological examination, medical history, vital signs, and electrocardiogram (ECG), and have a body mass index of 18-30 kilogram / square meter (kg/m^2) and a body mass of not less than 50 kg.
- Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day -1.
- Female participants must not be of childbearing potential by either being post-menopausal or permanently sterilized.
- Female participants must not be pregnant.
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, including contraception.
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and are willing to participate in the study.
Exclusion Criteria:
- Participant has current, or history of, clinically significant medical or psychiatric illness.
- Participant has any condition for which participation would not be in the best interest of the participant or that could prevent, limit, or confound any protocol specified assessments or the interpretation of the study results.
- Participant has a personal history of, or a first degree relative with a history of, acute angle-closure glaucoma, or participant has significant hyperopia (far-sightedness).
- Participant has a QT corrected according to Fridericia's formula (QTcF) interval greater than (>) 450 msec (male) or >470 msec (female), or has a history of additional risk factors for torsades de pointes.
- Participant has history of vasovagal episodes.
- Participant has history of drug, alcohol, nicotine, or caffeine abuse.
- Participant who is breastfeeding.
- Participant has had major surgery within 12 weeks of Screening, has donated more than 450 milliliters (mL) of blood, or has acute loss of equivalent amount of blood within 90 days of study drug administration.
- Participant has positive fecal occult blood test results at Screening.
- Participant has history of clinically significant drug and/or food allergies.
- Participant has received another investigational drug within 1 month or a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug
- Participant is an employee, or family member of an employee, of the study site.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Part 1: Single Ascending Dose (SAD)
Participants will receive 0.75 milligrams (mg) of JNJ-55375515 (starting dose) or Placebo on Day 1. Dose of the study medication will be escalated sequentially up to a maximum of 200 mg.
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Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.
Los participantes recibirán un placebo equivalente.
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Experimental: Part 2: Multiple Ascending Dose (MAD)
Participants will receive JNJ-55375515 (at doses determined based on the data from the SAD part) or Placebo from Day 1 to 10.
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Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.
Los participantes recibirán un placebo equivalente.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants with Adverse Events
Periodo de tiempo: Up to Day 7 after discharge
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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.
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Up to Day 7 after discharge
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Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Periodo de tiempo: Up to Day 5
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The Tmax is defined as actual sampling time to reach maximum observed concentration.
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Up to Day 5
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Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Periodo de tiempo: Up to Day 5
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The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
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Up to Day 5
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Part 1: Elimination Half-Life (t1/2)
Periodo de tiempo: Up to Day 5
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The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration.
It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
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Up to Day 5
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Part 1: Maximum Observed Plasma Concentration (Cmax)
Periodo de tiempo: Up to Day 5
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The Cmax is the maximum observed concentration.
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Up to Day 5
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Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Periodo de tiempo: Up to Day 15
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The Tmax is defined as actual sampling time to reach maximum observed concentration.
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Up to Day 15
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Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Periodo de tiempo: Up to Day 15
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The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
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Up to Day 15
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Part 2: Elimination Half-Life (t1/2)
Periodo de tiempo: Up to Day 15
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The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration.
It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
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Up to Day 15
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Part 2: Maximum Observed Plasma Concentration (Cmax)
Periodo de tiempo: Up to Day 15
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The Cmax is the maximum observed concentration.
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Up to Day 15
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximum Tolerated Dose (MTD) of JNJ-55375515
Periodo de tiempo: Up to Day 5 in part 1; up to Day 15 in part 2
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The maximum tolerated dose is defined as the dose below the dose at which 2 or more subjects receiving the same dose of active study drug experience the same dose-limiting toxicity or have the same severe adverse event, or below the level at which the Investigator and Sponsor agree that an unacceptable dose-limiting toxicity has occurred in a single subject treated with active study drug.
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Up to Day 5 in part 1; up to Day 15 in part 2
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Part 1: The Effect of Food on the Number of Adverse Events
Periodo de tiempo: Baseline up to Day 5
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Baseline up to Day 5
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Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Tmax)
Periodo de tiempo: Baseline up to Day 5
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Baseline up to Day 5
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Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Cmax)
Periodo de tiempo: Baseline up to Day 5
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Baseline up to Day 5
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Part 1: The Effect of Food on Elimination Half-Life (t1/2)
Periodo de tiempo: Baseline up to Day 5
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Baseline up to Day 5
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Part 1: The Effect of Food on Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
Periodo de tiempo: Baseline up to Day 5
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Baseline up to Day 5
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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
1 de noviembre de 2015
Finalización primaria (Actual)
1 de septiembre de 2016
Finalización del estudio (Actual)
1 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
18 de noviembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
2 de diciembre de 2015
Publicado por primera vez (Estimar)
7 de diciembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de diciembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
5 de diciembre de 2016
Última verificación
1 de diciembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CR108063
- 2015-003817-31 (Número EudraCT)
- 55375515EDI1001 (Otro identificador: Janssen Research & Development, LLC)
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. .