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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

Status

Concluído

Condições

Intervenção / Tratamento

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

    • Nottinghamshire
      • Nottingham, Nottinghamshire, Reino Unido, NG11 6JS
        • Quotient Clinical

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
Experimental: [14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Amount of radioactivity eliminated in urine
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in feces
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in urine and feces
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in feces
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine and feces
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: peak plasma concentration (Cmax)
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: time to reach maximum observed concentration (tmax)
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
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
Day 1 pre-dose to Day 8 post-dose
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
Day 1 pre-dose to Day 8 post-dose
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
Day 1 pre-dose to Day 8 post-dose
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
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: elimination half-life (t1/2)
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Metabolic profiling and structural identification in plasma, urine and feces
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

Medidas de resultados secundários

Medida de resultado
Prazo
Hematology
Prazo: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Clinical chemistry
Prazo: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Urinalysis
Prazo: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Blood pressure
Prazo: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Heart rate
Prazo: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Electrocardiogram
Prazo: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Percentage of subjects with adverse events
Prazo: Screening to Day 28
Screening to Day 28
Physical examination
Prazo: Screening and Day 8
Screening and Day 8
Tlag of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cmax of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Tmax of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUClast of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
%AUCextrap of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUCinf of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Lambda-z of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
T1/2 of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Mean Residence Time (MRT) of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Apparent oral clearance (CL/F) of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Apparent volume of distribution (Vz/F) of CORT125134
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of circulating radioactivity in plasma
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in urine
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in feces
Prazo: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

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

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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