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- Ensaio Clínico NCT02126514
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293 (AZD3293hADME)
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion After Oral Administration of [14C]-AZD3293 to Healthy Male Subjects
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Wisconsin
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Madison, Wisconsin, Estados Unidos
- Research Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria: Healthy male subjects between 18 and 55 years of age, inclusive, at the time of consent with suitable veins for cannulation or repeated venipuncture; 2) Body weight between 50 to 100 kg, inclusive; 3) Within BMI range 19 to 30 kg/m2, inclusive; 4) In good health, as determined by no clinically significant findings from medical history, physical examination with neurological examination, 12-lead ECG, and vital signs as judged by the Investigator;
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Exclusion Criteria:
Participation in any prior study of AZD3293 or previous enrollment in the present study; 2) Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, interfere with absorption, distribution, metabolism or excretion of drugs, or influence the results or the subject's ability to participate in the study; 3) History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
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Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: AZD3293
7 subjects will receive AZD3293
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7 subjects will receive AZD3293
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PK parameters measured by assessment of AUC over time and Maximum observed concentration (Cmax)
Prazo: Up to Day 25
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Maximum observed concentration (Cmax) parameters will be calculated, for AZD3293, its metabolite; and [14C]-AZD3293-derived total radioactivity.
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Up to Day 25
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs).
Prazo: Up to Day 25
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Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs), will be performed before and following investigational product administration.
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Up to Day 25
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The Columbia-Suicide Severity Rating Scale (C-SSRS)
Prazo: Up to day 25
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The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to assess the psychiatric health of subjects.
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Up to day 25
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Time to maximum observed concentration (tmax)
Prazo: Up to day 25
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Time to maximum observed concentration (tmax) will be calculated for AZD3293 and its metabolite; and [14C]-AZD3293-derived total radioactivity.
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Up to day 25
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Area under the concentration-time curve
Prazo: Up to day 25
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Area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t), will be calculated for AZD3293 and its metabolite ; and [14C]-AZD3293-derived total radioactivity concentrations.
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Up to day 25
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Area under the concentration-time curve extrapolated to infinity (AUC0-∞)
Prazo: Up to day 25
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Area under the concentration-time curve extrapolated to infinity (AUC0-∞), apparent terminal elimination rate constant (λZ), will be calculated for AZD3293 and its metabolite ; and [14C]-AZD3293-derived total radioactivity.
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Up to day 25
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Apparent terminal elimination half-life (t1/2)
Prazo: Up to day 25
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Apparent terminal elimination half-life (t1/2), will be calculated for AZD3293 and its metabolite; and [14C]-AZD3293-derived total radioactivity.
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Up to day 25
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Apparent oral clearance (CL/F)
Prazo: Up to day 25
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Apparent oral clearance (CL/F) (AZD3293 only), will be calculated for AZD3293 concentrations.
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Up to day 25
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Apparent volume of distribution (Vz/F)
Prazo: Up to day 25
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Apparent volume of distribution (Vz/F) (AZD3293 only) will be calculated for AZD3293 concentrations.
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Up to day 25
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Ratios for AUC0-
Prazo: Up to day 25
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Ratios for AUC0- including the ratio of total radioactivity in whole blood/plasma; and the ratio of AZD3293 in plasma and total radioactivity in plasma, will be calculated.
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Up to day 25
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- D5010C00007
- AZD3293 hADME (Outro identificador: AstraZeneca)
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