A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients
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
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Estágio
Estágio
- Fase 1
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: Sequência 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: Sequência 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: Sequência 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: Sequência 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: Sequência 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: Sequência 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Maximum observed concentration of abiraterone
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Number of participants affected by an adverse event
Prazo: Up to Day 21
|
Up to Day 21
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Inibidores da enzima citocromo P-450
- Antagonistas Hormonais
- Inibidores da Síntese de Esteróides
- Acetato de Abiraterona
Outros números de identificação do estudo
Outros números de identificação do estudo
- CR016960
- COU-AA-009 (Outro identificador: Cougar Biotechnology, Inc.)
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