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- Ensaio Clínico NCT01798628
A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients
22 de fevereiro de 2013 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
36
Estágio
- Fase 1
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
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
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / 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
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
Medida de resultado |
Prazo |
|---|---|
|
Number of participants affected by an adverse event
Prazo: Up to Day 21
|
Up to Day 21
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2009
Conclusão Primária (Real)
1 de outubro de 2009
Conclusão do estudo (Real)
1 de outubro de 2009
Datas de inscrição no estudo
Enviado pela primeira vez
22 de outubro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de fevereiro de 2013
Primeira postagem (Estimativa)
26 de fevereiro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de fevereiro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de fevereiro de 2013
Última verificação
1 de fevereiro de 2013
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
- CR016960
- COU-AA-009 (Outro identificador: Cougar Biotechnology, Inc.)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .