Human ADME Study of [14C]-AZD1390
10 de junho de 2026 atualizado por: AstraZeneca
A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies
This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
On Day 1, participants will receive one dose of [14C]-AZD1390 . Participants will be confined to the study site until Day 8.
Approximately 8 enrolled male and female participants will receive study intervention in order to achieve a minimum of 4 evaluable participants.
Participants in this study will contribute to essential knowledge that will support the development of AZD1390 as a potential treatment for GBM, a malignancy of high unmet need, while being exposed to a low level of immediate risk.
Tipo de estudo
Intervencional
Inscrição (Estimado)
8
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
Locais de estudo
-
-
-
Guildford, Reino Unido, GU2 7WG
- Research Site
-
Liverpool, Reino Unido, L7 8XP
- Research Site
-
-
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
Não
Descrição
Inclusion Criteria:
- Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,
- Predicted life expectancy ≥ 12 weeks,
- Adequate organ and marrow function,
- Creatinine clearance ≥ 50 mL/min,
- Regular bowel movements,
- No cancer-associated cachexia (weight loss).
Exclusion Criteria:
- History or presence of myopathy or raised CK > 5 × ULN at screening,
- History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,
- History or presence of clinically significant hepatic disease,
- History of epileptic disorder or any seizure history unrelated to tumour,
- History of MDS/AML or with features suggestive of MDS/AML,
- Predisposition to bleeding
- History of persisting (> 2 weeks) severe cytopenia
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection
- History of another primary malignancy
- Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy,
- Spinal cord compression or brain metastases for at least 4 weeks
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: AZD1390
Single dose of [14C]-AZD1390
|
single dose
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Amount excreted (Ae) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Cumulative Amount excreted (CumAe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Amount excreted (Ae) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Cumulative Amount excreted (CumAe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Amount excreted (Ae) (total - urine and feaces combined)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Cumulative Amount excreted (CumAe) (total urine and feaces combined)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Amount (percentage) excreted (Fe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Cumulative Amount (percentage) excreted (CumFe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Amount (percentage) excreted (Fe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Cumulative Amount (percentage) excreted (CumAe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Amount (percentage) excreted (Fe) (total urine and faeces combined)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Prazo: 6 Weeks
|
If emesis occurs, vomitus will be analysed for total radioactivity
|
6 Weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Maximum observed concentration (Cmax)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis whole blood: Maximum observed concentration (Cmax)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Prazo: 6 weeks
|
Analysis of urine: Cumulative amount excreted (CumAe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Prazo: 6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
The distribution of total radioactivity into blood cells after a single oral dose
Prazo: 6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Prazo: 6 weeks
|
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Prazo: 6 weeks
|
Analysis of urine: Renal clearance (CLR)
|
6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of plasma: Maximum observed concentration (Cmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Prazo: 6 weeks
|
Analysis of metabolite in plasma: parent ratio
|
6 weeks
|
|
Metabolic profiling following single oral dose of AZD1390
Prazo: 6 weeks
|
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Prazo: 6 weeks
|
Number of participants with AEs and SAEs and severity of AEs and SAEs (based on CTCAE v5).
|
6 weeks
|
|
The safety of a single dose of AZD1390
Prazo: 6 weeks
|
Number of participants with laboratory abnormalities based on assessment of Haematology/Haemostasis (whole blood), Urinalysis (dipstick), Serology, Clinical chemistry (serum or plasma), Creatinine clearance.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Prazo: 6 weeks
|
Number of participants with abnormal ECG and measurement of heart rate, PR QRS, QT and QTcF intervals (in milliseconds)
|
6 weeks
|
|
The safety of a single dose of AZD1390
Prazo: 6 weeks
|
Number of participants with abnormal vital signs based on assessment of body temperature, pulse rate, and blood pressure completed with automated devices.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Prazo: 6 weeks
|
Assessment of weight (measurement units can be variable) throughout the study.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Prazo: 6 weeks
|
Number of participants with abnormal physical examination based on assessment of general appearance, respiratory, cardiovascular, abdomen, skin, head and neck, lymph nodes, thyroid, musculoskeletal, and neurological systems.
|
6 weeks
|
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 (Estimado)
30 de junho de 2026
Conclusão Primária (Estimado)
12 de abril de 2028
Conclusão do estudo (Estimado)
12 de abril de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
18 de dezembro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de junho de 2026
Primeira postagem (Real)
12 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D6940C00006
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 at https://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 environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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
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 .