- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07625618
A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
-
-
Changchun
-
Jilin City, Changchun, Китай, 130000
- The First Hospital of Jilin University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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;
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: normal hepatic function 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.
|
|
Экспериментальный: 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.
|
|
Экспериментальный: moderate hepatic impairment (Child-Pugh B) group
|
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cmax
Временное ограничение: up to 12 weeks
|
maximum concentration
|
up to 12 weeks
|
|
AUC0-last
Временное ограничение: 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
Временное ограничение: up to 12 weeks
|
area under the plasma concentration-time curve from 0 to infinity
|
up to 12 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Tmax
Временное ограничение: up to 12 weeks
|
time to reach maximum concentration
|
up to 12 weeks
|
|
CL/F
Временное ограничение: up to 12 weeks
|
apparent clearance
|
up to 12 weeks
|
|
Vz/F
Временное ограничение: up to 12 weeks
|
apparent volume of distribution
|
up to 12 weeks
|
|
t1/2
Временное ограничение: up to 12 weeks
|
terminal half-life
|
up to 12 weeks
|
|
body temperature
Временное ограничение: up to 12 weeks
|
Measure the body temperature of the subjects, using degrees Celsius as the unit.
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up to 12 weeks
|
|
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
Временное ограничение: 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.
|
up to 12 weeks
|
|
12-lead ECG
Временное ограничение: up to 12 weeks
|
Evaluate QT interval, PR interval, etc.
|
up to 12 weeks
|
|
adverse events and serious adverse events
Временное ограничение: up to 12 weeks
|
up to 12 weeks
|
|
|
Pulse
Временное ограничение: up to 12 weeks
|
Measure the pulse of the subjects, expressing it in units of beats per minute.
|
up to 12 weeks
|
|
Blood pressure
Временное ограничение: up to 12 weeks
|
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
|
up to 12 weeks
|
Соавторы и исследователи
Следователи
- Главный следователь: YaNan Wang, PHD, The First Hospital of Jilin University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MY008211-1-09
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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