- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00940017
A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
5 de janeiro de 2010 atualizado por: Pfizer
A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects
The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
24
Estágio
- Fase 4
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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Connecticut
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Hartford, Connecticut, Estados Unidos, 06102
- Pfizer Investigational 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
Inclusion Criteria:
- Healthy adult subjects willing to comply with the study requirement.
Exclusion Criteria:
- Clinical significant disease.
- Sensitive to study medication.
- Not willing to comply with the study requirement.
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
- Alocação: 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: 1
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Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.
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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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Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
Prazo: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL).
Observed directly from the data.
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)
Prazo: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Tmax = time (hours) to maximum plasma concentration (Cmax).
Observed directly from data as time of first occurrence.
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)
Prazo: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL).
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Plasma Elimination Half-life (t1/2)
Prazo: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Total Clearance (CL Total)
Prazo: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min).
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Volume of Distribution at Steady-state (Vss)
Prazo: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Vss = volume of distribution at steady-state; measured as liters (L).
Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]).
MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Epithelial Lining Fluid (ELF) PK: Cmax
Prazo: 4, 8, 12, 24 hours after start of infusion
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Cmax=maximum observed plasma concentration.
ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL].
Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected.
Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).
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4, 8, 12, 24 hours after start of infusion
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ELF PK: Tmax
Prazo: 4, 8, 12, 24 hours after start of infusion
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Tmax = time (hours) to maximum plasma concentration (Cmax).
Observed directly from data as time of first occurrence.
ELF collected by bronchoscopy and BAL on Day 3.
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4, 8, 12, 24 hours after start of infusion
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ELF PK: AUCtau
Prazo: 4, 8, 12, 24 hours after start of infusion
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AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole.
ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
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4, 8, 12, 24 hours after start of infusion
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ELF PK: t1/2
Prazo: 4, 8, 12, 24 hours after start of infusion
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t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
ELF collected by bronchoscopy and BAL on Day 3.
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4, 8, 12, 24 hours after start of infusion
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Alveolar Macrophages (AM): Cmax
Prazo: 4, 8, 12, 24 hours after start of infusion
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Cmax = maximum observed plasma concentration; observed directly from the data.
AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
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4, 8, 12, 24 hours after start of infusion
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AM: Tmax
Prazo: 4, 8, 12, 24 hours after start of infusion
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Tmax = time (hours) to maximum plasma concentration (Cmax).
Observed directly from data as time of first occurrence.
AM collected by bronchoscopy and BAL on Day 3.
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4, 8, 12, 24 hours after start of infusion
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AM: AUCtau
Prazo: 4, 8, 12, 24 hours after start of infusion
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AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole.
AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
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4, 8, 12, 24 hours after start of infusion
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AM: t1/2
Prazo: 4, 8, 12, 24 hours after start of infusion
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t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
AM collected by bronchoscopy and BAL on Day 3.
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4, 8, 12, 24 hours after start of infusion
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Overall Drug Penetration Ratio in ELF
Prazo: 4, 8, 12, 24 hours after start of infusion
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ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole.
Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
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4, 8, 12, 24 hours after start of infusion
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Concentration Ratio in ELF to Plasma
Prazo: 4, 8, 12, 24 hours after start of infusion
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Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.
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4, 8, 12, 24 hours after start of infusion
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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 setembro de 2008
Conclusão Primária (Real)
1 de outubro de 2008
Conclusão do estudo (Real)
1 de outubro de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
13 de julho de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de julho de 2009
Primeira postagem (Estimativa)
15 de julho de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
9 de fevereiro de 2010
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de janeiro de 2010
Última verificação
1 de janeiro de 2010
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Infecções
- Síndrome da Resposta Inflamatória Sistêmica
- Inflamação
- Infecções Bacterianas e Micoses
- Sepse
- Micoses
- Infecções Fúngicas Invasivas
- Fungemia
- Candidíase
- Candidíase Invasiva
- Candidemia
- Aspergilose
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Inibidores Enzimáticos
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Inibidores do citocromo P-450 CYP3A
- Inibidores da enzima citocromo P-450
- Antagonistas Hormonais
- Antifúngicos
- Inibidores da Síntese de Esteróides
- Inibidores de 14-alfa desmetilase
- Anidulafungina
- Voriconazol
Outros números de identificação do estudo
- A8851020
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 .
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