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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03067376
A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body
7 de agosto de 2019 atualizado por: Corcept Therapeutics
An Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects
The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.
Visão geral do estudo
Descrição detalhada
The study was conducted to determine the recovery of [14C]-CORT125134 after the administration of a single oral dose of [14C]-CORT125134, to determine the routes and rate of elimination of [14C]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood.
Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces.
Safety and tolerability were assessed.
Tipo de estudo
Intervencional
Inscrição (Real)
9
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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Nottinghamshire
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Nottingham, Nottinghamshire, Reino Unido, NG11 6JS
- Quotient Clinical
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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
30 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Healthy males or healthy females of non-childbearing potential (surgically sterilized or postmenopausal [defined as a woman of with at least a 12 month history of amenorrhea with a follicle-stimulating hormone (FSH) >40 international units per liter (IU/L) in the absence of a reversible medical iatrogenic cause])
- Age 30 to 65 years of age
- A history of regular bowel movements (averaging ≥1 and ≤3 stools per day)
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Male participants must agree to use an adequate method of contraception
- Participants are willing to abide by the study restrictions
Exclusion Criteria:
- Participation in a clinical research study within the previous 3 months
- Participants who have previously been enrolled in this study or participants who have previously been treated with CORT125134
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliter (mL) of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 parts per million (ppm)
- Females of childbearing potential (female participants must have a negative urine pregnancy test)
- Male Participants with pregnant partners
- Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. The measurement includes exposure from the present study, and diagnostic x rays and other medical exposures, but excludes background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999.
- Positive drugs of abuse test result
- Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol) or herbal remedies in the 14 days before study drug administration. Hormone replacement therapy is not permitted
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: [14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Amount of radioactivity eliminated in urine
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Amount of radioactivity eliminated in feces
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Amount of radioactivity eliminated in urine and feces
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
|
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Cumulative amount of radioactivity eliminated in urine
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
|
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Cumulative amount of radioactivity eliminated in feces
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Cumulative amount of radioactivity eliminated in urine and feces
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: peak plasma concentration (Cmax)
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: time to reach maximum observed concentration (tmax)
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve (lambda-z)
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: elimination half-life (t1/2)
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Metabolic profiling and structural identification in plasma, urine and feces
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Hematology
Prazo: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Clinical chemistry
Prazo: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Urinalysis
Prazo: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Blood pressure
Prazo: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Heart rate
Prazo: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Electrocardiogram
Prazo: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Percentage of subjects with adverse events
Prazo: Screening to Day 28
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Screening to Day 28
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Physical examination
Prazo: Screening and Day 8
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Screening and Day 8
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Tlag of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Cmax of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Tmax of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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AUClast of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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%AUCextrap of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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AUCinf of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Lambda-z of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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T1/2 of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Mean Residence Time (MRT) of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Apparent oral clearance (CL/F) of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Apparent volume of distribution (Vz/F) of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of circulating radioactivity in plasma
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of the dose in urine
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of the dose in feces
Prazo: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Pui Leung, MBChB, Quotient Clinical
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 setembro de 2016
Conclusão do estudo (Real)
1 de setembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
6 de dezembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de fevereiro de 2017
Primeira postagem (Real)
1 de março de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de agosto de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de agosto de 2019
Última verificação
1 de agosto de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- CORT125134-121
- 2016-000668-41 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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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