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A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients

22 de febrero de 2013 actualizado por: Cougar Biotechnology, Inc.

A Phase 1, Single Dose, Open-Label, Three-Period, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Subjects

The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is an open-label (identity of assigned study drug will be known), randomized (treatment sequences will be assigned by chance) study of a single dose of abiraterone acetate 1000 mg administered orally (by mouth) in approximately 36 healthy male participants under fasted and fed conditions. Three doses of abiraterone acetate will be administered with a 7-day washout period between each dose. The total study duration for each participant will be 21 days. Participants will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA): Treatment A = abiraterone acetate 1000 mg administered after a high-fat meal; Treatment B = abiraterone acetate 1000 mg administered after a low-fat meal; Treatment C = abiraterone acetate 1000 mg administered in the fasted state. No food will be ingested for 4 hours post-dose. Participants will be confined at the clinical research unit from the day prior to dosing until clinic discharge on the day following dosing in each treatment period. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

36

Fase

  • Fase 1

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

Masculino

Descripción

Inclusion Criteria:

  • In good general health as determined by no clinically significant findings on medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory measurements
  • Body mass index within 18 kg/m2 to 32 kg/m2, inclusive
  • Non-tobacco users
  • Clinical laboratory values within protocol-defined parameters
  • Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]),and negative human immunodeficiency virus (HIV) antibody screens
  • Negative test for selected drugs of abuse
  • Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

  • Significant history or manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological or psychiatric disorder, as determined by the Principal Investigator
  • History or presence of an abnormal electrocardiogram
  • History of stomach or intestinal surgery resection that would potentially alter absorption and/or excretion of orally administered drugs
  • Screening serum total testosterone of <200 ng/dL
  • History of hypersensitivity reaction to the study drug, related compounds or excipients used in the formulation
  • Receipt of an investigational drug within 5 half-lives or 30 days prior to Day -1, whichever is longer
  • Abnormal diet during the 30 days prior to Day 1
  • Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day -1
  • Planned donation of blood or plasma from Screening through Study Completion, Day 21
  • Receipt of blood products within 2 months prior to Day 1
  • History of protocol-defined alcohol abuse
  • Known or suspected use of illicit drugs within the last year
  • Use of any medication on a chronic basis
  • Use of any prescription medications/products or over-the-counter non-prescription preparations within 5 half-lives or 7 days prior to Day -1 unless deemed acceptable by the Sponsor
  • Consumption of alcohol-containing foods or beverages within 24 hours prior to the first Check-in (Day -1)
  • Unwillingness to abstain from alcohol consumption from Day -1 to Study Completion (Day21)
  • Consumption of caffeine-containing or grapefruit-containing foods or beverages within 72 hours prior to Day -1
  • Unwillingness to abstain from caffeine-containing or grapefruit-containing foods or beverages from Day -1 through Study Completion (Day21)
  • Presence of sexual dysfunction or any medical condition that would affect sexual function
  • Unwillingness to refrain from strenuous exercise from 48 hours prior to Day -1 and for the duration of the study
  • Presence of any condition that, in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in this study
  • Unwillingness to refrain from using any tobacco or nicotine-containing products during screening and throughout the study to Study Completion (Day 21)

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: Secuencia ABC
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
Experimental: Secuencia ACB
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
Experimental: Secuencia BAC
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
Experimental: Secuencia BCA
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
Experimental: Secuencia CAB
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
Experimental: Secuencia CBA
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Maximum observed concentration of abiraterone
Periodo de tiempo: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Time to maximum concentration of abiraterone
Periodo de tiempo: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Area under the concentration-time curve from time 0 to the last measurable concentration of abiraterone
Periodo de tiempo: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Area under the concentration-time curve extrapolated to infinity of abiraterone
Periodo de tiempo: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Apparent plasma terminal elimination rate constant of abiraterone
Periodo de tiempo: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Apparent terminal elimination half-life of abiraterone
Periodo de tiempo: Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Number of participants affected by an adverse event
Periodo de tiempo: Up to Day 21
Up to Day 21

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 septiembre de 2009

Finalización primaria (Actual)

1 de octubre de 2009

Finalización del estudio (Actual)

1 de octubre de 2009

Fechas de registro del estudio

Enviado por primera vez

22 de octubre de 2012

Primero enviado que cumplió con los criterios de control de calidad

22 de febrero de 2013

Publicado por primera vez (Estimar)

26 de febrero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de febrero de 2013

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

22 de febrero de 2013

Última verificación

1 de febrero de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CR016960
  • COU-AA-009 (Otro identificador: Cougar Biotechnology, Inc.)

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. .