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- Ensaio Clínico NCT07936058
A Phase I Study to Evaluate the Food Effect on Ecnoglutide Tablet
A Randomized, Open-label, Multiple-dose, Multicenter Phase I Study to Evaluate the Food Effect on the Pharmacokinetics of Ecnoglutide Tablets in Chinese Adult Participants
The aim of the study is to evaluate food effect on pharmacokinetics of oral ecnoglutide tablets in Chinese participants
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
There are two parts in this study. Part I will assess the effect of high-fat meal, while eligible participants will be randomized and allocated to either cohort F1(fasting) or F2(with meal) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days. Part II will assess the effect of different dosing conditions, while eligible participants will be randomized and allocated to either cohort T1(no intake after 30min of dosing) or T2(no intake after 60min of dosing) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Yao Li
- Número de telefone: 010-67889253
- E-mail: ra@sciwindbio.com
Locais de estudo
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Zhejiang Provincial People's Hospital
-
Contato:
- Yiwen Zhang
- Número de telefone: 0571-85893643
- E-mail: ra@sciwindbio.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Body mass index (BMI): 19.0 kg/m² ≤ BMI < 30.0 kg/m², with body weight ≥ 55 kg (male) or ≥ 50 kg (female);
- Participants of childbearing potential agree to have no plans for pregnancy during the entire study period and within 6 months after the last dose: female participants must be non-pregnant and non-lactating, with no plans to donate ova, and male participants must have no plans to donate sperm; all participants voluntarily use effective contraception, with female participants avoiding pregnancy and male participants avoiding causing pregnancy in their partners;
Exclusion Criteria:
- History of severe drug allergy (especially known or suspected allergy to any component of Ecnoglutide Tablets, regardless of the severity of previous allergic reactions), or severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis, etc.), or discretion by the investigator to have a severe allergic condition (e.g., allergy to two or more drugs/foods, or repeated allergic reactions requiring medical intervention);
- Diagnosis of overweight or obesity of endocrine origin, such as Cushing's syndrome;
- Diagnosis of diabetes mellitus of any type (excluding gestational diabetes mellitus);
- History of acute or chronic pancreatitis, pancreatic injury, symptomatic biliary disease, or other high-risk factors that may lead to pancreatitis;
- Diagnosis of other endocrine diseases of significant clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging showing C-TIRADS ≥ 4A), thyroid cancer, or a personal or family history of multiple endocrine neoplasia type 2 (MEN2);
- Occurrence of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, severe irritable bowel syndrome, celiac disease, recurrent dyspepsia, or clinically abnormal gastric emptying (e.g., pyloric obstruction), within 6 months prior to screening; or presence of gastrointestinal symptoms such as nausea, vomiting, diarrhea, or constipation at screening/before the first dose;
- Occurrence of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 episodes within 6 months) (e.g., anxiety, dizziness, sweating, tremor, hunger, and poor concentration, etc.), within 6 months prior to screening;
- Diagnosis of malignant tumor within 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc., as discreted by the investigator to be clinically insignificant;
- History of depression, or other severe psychiatric illness, or suicidal ideation or suicidal behavior;
- Within 3 months prior to screening, participation in and use of any investigational drug, vaccine, special medical food, or invasive device clinical trial, or planned participation in other clinical trials during the study period;
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: F1
Day 1 to Day 14: Fast overnight for at least 10 hours before each dose, and take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration. |
oral, once daily for 7 days oral, once daily for 7 days |
|
Experimental: F2
Day 1 to Day 13: take breakfast within 30min before each dose, and then take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration. Day 14: take breakfast with high fat and high calorie |
oral, once daily for 7 days oral, once daily for 7 days |
|
Experimental: T1
Day 1 to Day 14: fast after 30min of dosing |
oral, once daily for 7 days oral, once daily for 7 days |
|
Experimental: T2
Day 1 to Day 14: fast after 60min of dosing |
oral, once daily for 7 days oral, once daily for 7 days |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum concentration
Prazo: From Day1 to Day42
|
Cmax of ecnoglutide |
From Day1 to Day42
|
|
Minimum concentration
Prazo: From Day1 to Day42
|
Cmin of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to infinity
Prazo: From Day1 to Day42
|
AUC0-∞of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to 24h
Prazo: From Day1 to Day42
|
AUC0-24h of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to last quantifiable time point
Prazo: From Day1 to Day42
|
AUC0-t of ecnoglutide |
From Day1 to Day42
|
|
Time to reach maximum concentration
Prazo: From Day1 to Day42
|
Tmax of ecnoglutide |
From Day1 to Day42
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The incidence of adverse events
Prazo: From Day1 to Day42
|
From Day1 to Day42
|
|
|
Anti-drug antibody
Prazo: From Day1 to Day42
|
ADA of ecnoglutide |
From Day1 to Day42
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yiwen Zhang, Zhejiang Provincial People's Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SCW0503-1013
Plano para dados de participantes individuais (IPD)
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Informações sobre medicamentos e dispositivos, documentos de estudo
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