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A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Participants

24 de junio de 2014 actualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Open-Label, Two-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Male and Female Subjects

The purpose of this study is to evaluate the effect of food on the bioavailability of a single oral dose of JNJ-39823277 and its active metabolites.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), single-center, 2 treatment-sequence, and crossover study (method used to switch participants from one treatment arm to another in a clinical study). The study consist of 3 phases: a screening phase (within 21 days before medication administration), a 2-period open-label treatment phase, during which each participant will receive 1 of 2 open-label treatment sequences, and the end-of-study or withdrawal assessments (within 7-11 days after the last dose of the study medication). Participants will be randomly assigned to 1 of 2 treatment-sequences: Treatment Sequence AB (dosing in fed [with high fat diet] condition followed by dosing in fasted [without food] condition) or Treatment Sequence BA (dosing in fasted condition followed by dosing in fed condition). Study medication administrations will be separated by a washout period (period when receiving no treatment) of 7 to 14 days. The study duration for each participant will be approximately 6 weeks.

Tipo de estudio

Intervencionista

Inscripción (Actual)

32

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

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 55 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Participant must be a healthy male or non-lactating healthy female
  • Agrees to protocol-defined use of effective contraception
  • If a woman, must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and on Day -1 of each treatment period
  • Agree to abstain from all medication (except for allowed birth control), including prescription and non-prescription (including vitamins and natural or herbal remedies)

Exclusion Criteria:

  • A history of clinically significant gastrointestinal, especially peptic ulcerations, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, especially those with a past history of depression, suicidal ideation or suicidal attempts, or cardiovascular disease
  • Acute diarrhea or constipation in the 7 days before the predicted first study day. If screen occurs >7 days before first study day, this criterion will be determined on Day -1
  • Participant has donated blood within 90 days or plasma within 30 days of study dosing
  • Participant has used any over-the-counter or prescription medication, including vitamins, within 14 days prior to the study with the exception of acetaminophen
  • Participant has consumed products containing grapefruit juice or grapefruit, Seville oranges (eg, orange marmalade), quinine (eg, tonic water), or xanthine (eg, chocolate, caffeine containing products) within 24 hours (72 hours in the case of grapefruit juice and Seville oranges) prior to start of study drug administration

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 cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment A
Participants will receive 100 mg JNJ-39823277 under fed (after a high fat) condition.
Droga: JNJ-39823277
Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
Otros nombres:
  • TPI-1062
Experimental: Treatment B
Participants will receive 100 mg JNJ-39823277 under fasted condition.
Droga: JNJ-39823277
Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
Otros nombres:
  • TPI-1062

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maximum Observed Plasma Concentration (Cmax) of JNJ-39823277
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The Cmax is defined as maximum observed analyte concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-39823277
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-39823277
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-39823277
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Elimination Half-Life Period (T1/2) of JNJ-39823277
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The 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 rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of JNJ-40917006 (MC5 metabolite)
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The Cmax is defined as maximum observed analyte concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-40917006 (MC5 metabolite)
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-40917006 (MC5 metabolite)
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-40917006 (MC5 metabolite)
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
Elimination Half-Life Period (T1/2) of JNJ-40917006 (MC5 metabolite)
Periodo de tiempo: Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose
The 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 rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Number of participants with adverse events as a measure of safety and tolerability
Periodo de tiempo: Up to 6 weeks
Up to 6 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigadores

  • Director de estudio: Johnson & Johnson Pharmaceutical Research and Development, L.L C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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 mayo de 2009

Finalización primaria (Actual)

1 de junio de 2009

Finalización del estudio (Actual)

1 de junio de 2009

Fechas de registro del estudio

Enviado por primera vez

1 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

1 de abril de 2014

Publicado por primera vez (Estimar)

4 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

25 de junio de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

24 de junio de 2014

Última verificación

1 de junio de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • CR015718
  • TPI1062DEP1004 (Otro identificador: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

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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