A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954
4 de setembro de 2026 atualizado por: AstraZeneca
An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and Absolute Bioavailability of AZD4954 in Healthy Male Participants
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This two-part study will take place at one site in Nottingham, United Kingdom, and will enroll 8 healthy men in each part, aged 30-65 years.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This study will take place at one site in Nottingham, United Kingdom.
It is planned to enroll 8 healthy male participants in each part, aged 30-65 years.
In part 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth. They'll stay in the clinic for up to 24 nights, attend 1 outpatient visit, and take up to 8 weeks to finish the study.
In part 2 volunteers will receive a single dose of test medicine by mouth and, shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein. They'll stay in the clinic for up to 15 nights, attend 1 outpatient visit, and take up to 7 weeks to finish the study.
Blood and urine samples will be collected to do safety tests. Blood, urine and faecal samples will be collected to measure the amount of test medicine and its breakdown products.
Tipo de estudo
Intervencional
Inscrição (Estimado)
16
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.
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Healthy males aged 30 to 65 years inclusive
- BMI of 18.0 to 35.0 kg/m2 inclusive
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment
- History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder
- History of cholecystectomy or gall stones
- History of GI surgery
- Acute diarrhoea or constipation in the 7 days before the predicted Day 1
- Participants who do not have suitable veins for multiple venepunctures/cannulation
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
- Evidence of renal impairment at screening
- Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Participants who have previously been administered IMP in this study
- Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
- Participants who have been administered IMP in an ADME study in the last 12 months
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing
- Current smokers or known or suspected history of alcohol or drug abuse
- Excessive intake of caffeine-containing drinks or food
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: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Part 1
Participants in Part 1 will receive a single dose of [14C]AZD4954 Oral Solution.
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Participants in Part 1 will recieve a single dose of [14C]AZD4954 oral solution
|
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Experimental: Part 2
Participants in Part 2 will receive a single unlabelled oral dose of AZD4954 tablet and a radiolabelled IV microtracer dose of [14C]AZD4954.
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Participants in Part 2 will receive a single dose of AZD4954 film-coated tablet by mouth
Participants in Part 2 will receive a single very tiny dose of radiolabelled [14C]AZD4954 Solution for Infusion as a slow injection into a vein
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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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Amount of AZD4954 excreted (Ae) (Part 1)
Prazo: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
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Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Amount of AZD4954 excreted expressed as a fraction of dose excreted (Fe) (Part 1)
Prazo: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
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Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Cumulative amount of AZD4954 excreted (CumAe) (Part 1)
Prazo: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
|
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
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Cumulative amount of AZD4954 excreted expressed as a fraction of dose excreted (CumFe) (Part 1)
Prazo: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
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Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Absolute bioavailability (F) based on AUC0-inf (Part 2)
Prazo: Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
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Absolute bioavailability of AZD4954 oral and IV administration, adjusted for dose
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Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum observed concentration (Cmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Prazo: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
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Time of maximum observed concentration (Tmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Prazo: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
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The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
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Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4954 and total radioactivity (Parts 1 and 2)
Prazo: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
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The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
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Terminal elimination half-life (T1/2) for AZD4954 and total radioactivity (Parts 1 and 2)
Prazo: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
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The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
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Area under the curve (AUC) of circulating total radioactivity accounting for 10% or more of the dose (Part 1)
Prazo: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Identification of the chemical structure of each metabolite
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Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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80% or more of the radioactivity recovered in excreta (Part 1)
Prazo: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Identification of the chemical structure of each metabolite
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Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Disposition of total radioactivity in plasma and in blood (Part 1)
Prazo: Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
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Evaluation of whole blood:plasma concentration ratios for total radioactivity
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Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Quotient Sciences
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 (Estimado)
19 de outubro de 2026
Conclusão Primária (Estimado)
17 de dezembro de 2026
Conclusão do estudo (Estimado)
17 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
4 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de setembro de 2026
Primeira postagem (Real)
10 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de setembro de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- D7300C00005
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org.
All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Prazo de Compartilhamento de IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Critérios de acesso de compartilhamento IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .