A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.
It is planned to enroll 24 subjects, male or female. A total of 3 treatment groups will be set up: normal hepatic function group, mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, with 8 subjects in each group. Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
This study will first enroll subjects in Group A (mild hepatic impairment) and Group B (moderate hepatic impairment). Age, gender and body weight will not be matched between subjects in Groups A and B; after enrollment for Groups A and B is completed, subjects will be enrolled in Group C (normal hepatic function) as control subjects matched with the hepatic impairment subjects (Group A + Group B):
Subjects who sign the informed consent form (ICF) will be screened according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (D-1). On D1, they will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions and will be discharged after completing the observations and drop-out examinations on D4. They will receive a telephone follow-up on D11.
During the study, sample collection, recording of adverse events (AEs), concomitant medication/non-drug therapy, physical examination, vital signs, ECG, and clinical laboratory tests will be performed according to the protocol requirements.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Changchun
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Jilin City, Changchun, China, 130000
- The First Hospital of Jilin University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Voluntarily participate in the clinical study and sign the written ICF, be able to understand the procedures and methods of this study, and be able to complete the entire study process according to the study requirements;
- Age 18 to 70 years (inclusive) on the day of signing the ICF, male or female;
- Body weight: ≥ 50 kg for males, ≥ 45 kg for females; body mass index (BMI): 18.0-32.0 kg/m2 (both inclusive);
- Subjects (including their partners) have no birth plan from screening until 3 months after the administration of the investigational product and voluntarily take contraceptive measures, and have no plans to donate sperm or eggs;
- Glomerular filtration rate (calculated using the CKD-EPI formula) ≥ 60 mL/min;
Exclusion Criteria:
- Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), hereditary or acquired complement deficiency;
- Clear history of capsular microbial infection within 6 months before screening, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae and Legionella pneumophila.
- Subjects who have a previous history of tuberculosis infection or are currently suffering from tuberculosis infection;
- Active systemic bacterial, viral or fungal infections within 14 days before administration;
- Fever (≥ 38°C) within 7 days before administration;
- Subjects suspected of having a history of allergy to any component of the investigational product, or with allergic constitution (allergic to multiple drugs and foods, and judged by the investigator to be clinically significant);
- Those who have previously undergone surgery that, as judged by the investigator, will affect drug absorption, distribution, metabolism and excretion; or those who have undergone surgery within 4 weeks prior to screening; or those who plan to undergo surgery during the study;
- Those who cannot tolerate venipuncture or with a history of blood phobia and acupuncture syncope;
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: normal hepatic function group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
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Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
|
|
Experimental: mild hepatic impairment (Child-Pugh A) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
|
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
|
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Experimental: moderate hepatic impairment (Child-Pugh B) group
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Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cmax
Prazo: up to 12 weeks
|
maximum concentration
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up to 12 weeks
|
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AUC0-last
Prazo: up to 12 weeks
|
area under the plasma concentration-time curve from 0 to the last quantifiable time point
|
up to 12 weeks
|
|
AUC0-inf
Prazo: up to 12 weeks
|
area under the plasma concentration-time curve from 0 to infinity
|
up to 12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tmax
Prazo: up to 12 weeks
|
time to reach maximum concentration
|
up to 12 weeks
|
|
CL/F
Prazo: up to 12 weeks
|
apparent clearance
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up to 12 weeks
|
|
Vz/F
Prazo: up to 12 weeks
|
apparent volume of distribution
|
up to 12 weeks
|
|
t1/2
Prazo: up to 12 weeks
|
terminal half-life
|
up to 12 weeks
|
|
body temperature
Prazo: up to 12 weeks
|
Measure the body temperature of the subjects, using degrees Celsius as the unit.
|
up to 12 weeks
|
|
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
Prazo: up to 12 weeks
|
The blood human chorionic gonadotropin (HCG) pregnancy test will measure the concentration of HCG in the blood of reproductive-aged women to determine if they are pregnant.
The units in the report will be presented in IU/L (international units per liter) and/or mIU/mL.
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up to 12 weeks
|
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12-lead ECG
Prazo: up to 12 weeks
|
Evaluate QT interval, PR interval, etc.
|
up to 12 weeks
|
|
adverse events and serious adverse events
Prazo: up to 12 weeks
|
up to 12 weeks
|
|
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Pulse
Prazo: up to 12 weeks
|
Measure the pulse of the subjects, expressing it in units of beats per minute.
|
up to 12 weeks
|
|
Blood pressure
Prazo: up to 12 weeks
|
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
|
up to 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: YaNan Wang, PHD, The First Hospital of Jilin University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MY008211-1-09
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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