A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
1 de março de 2016 atualizado por: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia.
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
40
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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Brussels, Bélgica, B-1070
- Pfizer Clinical Research Unit
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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
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Healthy male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
- Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast
Exclusion Criteria:
•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
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: Ciência básica
- Alocação: Randomizado
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Cohort 1
Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Experimental: Cohort 2
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Experimental: Cohort 3
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Experimental: Cohort 4
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Experimental: Cohort 5
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Experimental: Cohort 6
Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Assessment of adverse events (AEs).
Prazo: 0-25 days
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0-25 days
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Assessment of clinical laboratory tests.
Prazo: 0-25 days
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0-25 days
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Assessment of vital signs (including blood pressure and pulse rate).
Prazo: 0-25 days
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0-25 days
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Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Prazo: 0-25 days
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0-25 days
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
Prazo: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
Prazo: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
Prazo: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0- tau hours post dose
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0- tau hours post dose
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Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0- tau hours post dose
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0- tau hours post dose
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Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Prazo: 0- tau hours post dose
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0- tau hours post dose
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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 março de 2015
Conclusão Primária (Real)
1 de fevereiro de 2016
Conclusão do estudo (Real)
1 de fevereiro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
12 de março de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de março de 2015
Primeira postagem (Estimativa)
18 de março de 2015
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
2 de março de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de março de 2016
Última verificação
1 de março de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- B7871002
- 2015-000130-29 (Número EudraCT)
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 .