PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants
7 de março de 2017 atualizado por: Biogen
A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects
The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants.
The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
64
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Leeds, Reino Unido, LS2 9LH
- Research Site
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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
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Key Inclusion Criteria:
- Japanese or Caucasian.
- Japanese participants must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
- Must have a body mass index between 18 and 30 kg/m2, inclusive.
Key Exclusion Criteria:
- Previous exposure to BIIB074, with the exception that Japanese participants who complete Part 1.
- Use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of Day -1 and an unwillingness to refrain from product use during study participation.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Part 1
48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio
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Administrado conforme especificado no braço de tratamento
Outros nomes:
Placebo correspondente
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Experimental: Part 2
16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily [TID] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily [BID] in cohort 5 for 6 days and QD for 1 day
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Administrado conforme especificado no braço de tratamento
Outros nomes:
Placebo correspondente
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )
Prazo: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)
Prazo: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)
Prazo: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)
Prazo: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)
Prazo: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)
Prazo: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)
Prazo: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)
Prazo: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by tmax
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC
Prazo: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Number of participants with clinically significant laboratory assessment abnormalities
Prazo: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Number of participants with clinically significant vital sign abnormalities
Prazo: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Prazo: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Number of participants with clinically significant physical examinations abnormalities
Prazo: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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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 agosto de 2016
Conclusão Primária (Real)
1 de fevereiro de 2017
Conclusão do estudo (Real)
1 de fevereiro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
11 de julho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de julho de 2016
Primeira postagem (Estimativa)
13 de julho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de março de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de março de 2017
Última verificação
1 de março de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 802HV106
- 2016-000874-39 (Número EudraCT)
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