- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03770039
Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
5 de março de 2019 atualizado por: Pfizer
A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C-PF-06700841] AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06700841 IN HEALTHY MALE SUBJECTS USING A 14C-MICROTRACER APPROACH
An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
6
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
-
-
-
Groningen, Holanda, 9728 NZ
- PRA Health Sciences
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Utrecht, Holanda, 3584 BL
- PRA Health Sciences Utrecht
-
-
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
Macho
Descrição
Exclusion Criteria:
- Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
- Total 14C radioactivity measured in plasma exceeding 11 mBq/mL
- History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test
- Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine cotinine test
- Use of herbal supplements within 28 days prior to the first dose of study medication
- Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen 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 Pfizer
- Inability to have at least one bowel movement every 2 days on average eGFR of <90 mL/mim/1.73 m2 based on MDRD equation
- Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.
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: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 2-period, fixed sequence
fixed sequence with 2 treatment period
|
Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period
60 mg unlabeled PF-06700841 oral dose in 2nd period
30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
mass balance_urine
Prazo: hour 0 up to 312 hours post dose
|
cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered
|
hour 0 up to 312 hours post dose
|
|
mass balance_feces
Prazo: hour 0 up to 312 hours post dose
|
cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered
|
hour 0 up to 312 hours post dose
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
metabolite identification_plasma
Prazo: hour 0 up to 312 hours post dose
|
metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma Cmax for total 14C radioactivity
Prazo: hour 0 up to 312 hours post dose
|
maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma Tmax for total 14C radioactivity
Prazo: hour 0 up to 312 hours post dose
|
time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma AUClast for total 14C radioactivity
Prazo: hour 0 up to 312 hours post dose
|
area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma AUCinf for total 14C radioactivity
Prazo: hour 0 up to 312 hours post dose
|
area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
Oral clearance for total 14C radioactivity
Prazo: hour 0 up to 312 hours post dose
|
oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma half-life for total 14C radioactivity
Prazo: hour 0 up to 312 hours post dose
|
half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
volume of distribution for total 14C radioactivity
Prazo: hour 0 up to 312 hours post dose
|
apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma Cmax for PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma Tmax for PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma AUClast for PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
area under curve of PF-06700841 in plasma from time 0 to tlast following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma AUCinf for PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
area under curve of PF-06700841 in plasma from time 0 to infinite following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
Oral clearance for PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma half-life for PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
volume of distribution for PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma Cmax for 14C-labeled PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma Tmax for 14C-labeled PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma AUClast for 14C-labeled PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
area under curve of 14C-labeled PF-06700841 in plasma from time 0 to tlast following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma AUCinf for 14C-labeled PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
clearance for 14C-labeled PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma half-life for 14C-labeled PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
volume of distribution for 14C-labeled PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
unchanged PF-06700841 recovered in urine
Prazo: hour 0 up to 96 hours post dose
|
percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841
|
hour 0 up to 96 hours post dose
|
|
renal clearance of PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841)
|
hour 0 up to 96 hours post dose
|
|
Bioavailability of oral PF-06700841
Prazo: hour 0 up to 96 hours post dose
|
Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841
|
hour 0 up to 96 hours post dose
|
|
Fraction absorbed of oral PF-06700841
Prazo: hour 0 up to 144 hours post dose
|
Fraction absorbed in gut (Fa) following oral dose of PF-06700841
|
hour 0 up to 144 hours post dose
|
|
metabolite identification_urine
Prazo: hour 0 up to 312 hours post dose
|
metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
metabolite identification_feces
Prazo: hour 0 up to 312 hours post dose
|
metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
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 (Real)
10 de dezembro de 2018
Conclusão Primária (Real)
21 de fevereiro de 2019
Conclusão do estudo (Real)
21 de fevereiro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
6 de dezembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de dezembro de 2018
Primeira postagem (Real)
10 de dezembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de março de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de março de 2019
Última verificação
1 de março de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B7931014
- 2018-002403-34 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Descrição do plano IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
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 .