A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Estágio
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Bruxelles, Bélgica, B-1070
- Pfizer Investigational Site
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Women must be of non-childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: Coorte 1
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Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
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Experimental: Coorte 2
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Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
|
Experimental: Coorte 3
|
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
|
Experimental: Coorte 4
|
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
|
Experimental: Coorte 5
|
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
Prazo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Prazo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
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Area Under the Curve From Time Zero to 24 hour [AUC24]
Prazo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
|
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Maximum Observed Plasma Concentration (Cmax)
Prazo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Prazo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
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Apparent Oral Clearance (CL/F)
Prazo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
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Plasma Decay Half-Life (t1/2)
Prazo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
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Apparent Volume of Distribution (Vz/F)
Prazo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
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Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)
Prazo: 0 to 24 hours post-dose
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0 to 24 hours post-dose
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Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)
Prazo: 0 to 24 hours post-dose
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0 to 24 hours post-dose
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Renal Clearance (CLr)
Prazo: 0 to 24 hours post-dose
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0 to 24 hours post-dose
|
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Oral temperature
Prazo: 0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose
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0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Publicações e links úteis
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
Outros números de identificação do estudo
Outros números de identificação do estudo
- B5211001
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