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A Phase 4 Study to Evaluate Pharmacokinetics and Safety of Darunavir Along With Ritonavir in Healthy Male Japanese Participants

9 de abril de 2013 actualizado por: Janssen Pharmaceutical K.K.

A Study to Evaluate the Pharmacokinetics and Safety of Oral Single-Dose JNS011 Tablet in Combination With Low-Dose Ritonavir Capsule in Healthy Japanese Adult Males

The purpose of this study is to evaluate the pharmacokinetics (explores what the body does to the drug) and safety of darunavir, and will be administered in combination with Ritonavir in healthy adult Japanese male participants.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is an open-label (all people know the identity of the intervention), single oral-dose and post-marketing study of darunavir administered in combination with low-dose ritonavir in healthy adult Japanese male participants. The total study duration will be approximately of 14 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1); Treatment (that is, Day 1-5); and Follow-up (that is, up to Day 13). The participants will be hospitalized for 6 nights and 7 days. All the eligible participants will receive Darunavir oral tablet on Day 3 and ritonavir capsule orally twice daily from Day 1-5. Participants will keep upright position until 4 hours after study drug administration. Both the drugs will be administered within 15 minutes after completion of meal. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

8

Fase

  • Fase 4

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

20 años a 40 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

  • Male Participants provided with sufficient explanation of the investigational product, the drugs to be provided and this clinical study prior to the start of participation in the clinical study, and capable of providing voluntary informed consent in writing
  • Male Participants with a Body Mass Index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m^2) at the time of the Screening tests
  • Non-smokers or male participants who are capable of abstaining from smoking during the period from the day before the Screening tests until the completion of the post-treatment examinations
  • Male Participants consenting to use a medically-approved contraceptive method (such as condoms or the like) during the period from hospital admission until the completion of the post-treatment examinations
  • Male Participants showing no clinically significant abnormalities at the time of Screening, on the day prior

Exclusion Criteria:

  • Participants suffering or with a history of diseases related to the liver, kidneys, circulatory system, respiratory system, digestive system, neuropsychiatric system, hematopoietic function or endocrine function and who may be inappropriate for participation in this clinical study
  • Participants who participated in another clinical study and were treated with another investigational product within 120 days prior to the start of the initial dosing of the provided drugs
  • Participants giving 200 milliliter (mL) or more of blood within 30 days prior to the start of the initial dosing of the provided drugs or giving 400 mL or more of blood within 90 days prior to the start of the initial dosing of the provided drugs (such as blood donation), or giving a total of 1200 mL or more of blood within the past year
  • Participants with a history of hypersensitivity to sulfonamide drugs, drug allergies or drug hypersensitivity, alcohol, pharmaceutical or drug addiction, or who may be addicted
  • Participants with positive results for Human Immunodeficiency Virus antigen or antibodies, Hepatitis C Virus antibodies, Hepatitis B Surface antigen or the serological test for syphilis

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Ritonavir and darunavir
Ritonavir will be administered orally twice daily at a dose of 100 milligram (mg) from Day 1-5. Darunavir ethanolate will be administered as single oral dosing of two tablets of 300 mg on Day 3.
Droga: Darunavir
Darunavir ethanolate will be administered as single oral dosing of two tablets of 300 milligram (mg) on Day 3.
Otros nombres:
  • JNS011
Droga: Ritonavir
Ritonavir capsule will be administered orally twice daily at a dose of 100 mg for 5 days.
Otros nombres:
  • Ritonavir will be administered orally twice daily as 100 mg capsule from Day 1-5.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Plasma Darunavir Concentration
Periodo de tiempo: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Plasma concentration of Darunavir will be determined by collecting blood samples at the defined time points.
0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Maximum Plasma Concentration (Cmax) of Darunavir
Periodo de tiempo: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
The Cmax is the maximum plasma concentration.
0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Darunavir
Periodo de tiempo: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Terminal Half-Life(t[1/2]) of Darunavir
Periodo de tiempo: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Terminal half-life (t[(1/2]) is defined as 0.693/Lambda(z).
0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Time to reach maximum concentration (tmax) of Darunavir
Periodo de tiempo: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
The Tmax is time to reach the maximum plasma concentration.
0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of Darunavir
Periodo de tiempo: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Apparent total body clearance (CL/F) of Darunavir
Periodo de tiempo: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity)
0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Apparent volume of distribution at the terminal Phase (Vd[z] /F) of Darunavir
Periodo de tiempo: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).
0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Plasma Ritonavir Concentration
Periodo de tiempo: 0 hour (pre-dose) on Day 1, 2, 3, 4 and 5
Plasma concentration of Darunavir will be determined by collecting blood samples at the defined time points.
0 hour (pre-dose) on Day 1, 2, 3, 4 and 5
Maximum Plasma Concentration (Cmax) of Ritonavir
Periodo de tiempo: 0 hour (pre-dose) on Day 1, 2, 3, 4 and 5
The Cmax is the maximum plasma concentration.
0 hour (pre-dose) on Day 1, 2, 3, 4 and 5
Time to reach maximum concentration (tmax) of Ritonavir
Periodo de tiempo: 0 hour (pre-dose) on Day 1, 2, 3, 4 and 5
The Tmax is time to reach the maximum plasma concentration.
0 hour (pre-dose) on Day 1, 2, 3, 4 and 5
Area Under the Plasma Concentration-Time Curve From Time Zero to 12 hours (AUC [0-12]) of Ritonavir
Periodo de tiempo: 0 hour (pre-dose) on Day 1, 2, 3, 4 and 5
The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
0 hour (pre-dose) on Day 1, 2, 3, 4 and 5

Colaboradores e Investigadores

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

Patrocinador

Janssen Pharmaceutical K.K.

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 2008

Finalización primaria (Actual)

1 de julio de 2008

Finalización del estudio (Actual)

1 de julio de 2008

Fechas de registro del estudio

Enviado por primera vez

12 de marzo de 2013

Primero enviado que cumplió con los criterios de control de calidad

12 de marzo de 2013

Publicado por primera vez (Estimar)

14 de marzo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

10 de abril de 2013

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

9 de abril de 2013

Última verificación

1 de abril de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR100323
  • JNS011-JPN-01

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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