A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Changchun
-
Jilin City、Changchun、中国、130000
- The First Hospital of Jilin University
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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;
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
|
实验性的: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.
|
|
实验性的:moderate hepatic impairment (Child-Pugh B) group
|
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cmax
大体时间:up to 12 weeks
|
maximum concentration
|
up to 12 weeks
|
|
AUC0-last
大体时间: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
大体时间:up to 12 weeks
|
area under the plasma concentration-time curve from 0 to infinity
|
up to 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tmax
大体时间:up to 12 weeks
|
time to reach maximum concentration
|
up to 12 weeks
|
|
CL/F
大体时间:up to 12 weeks
|
apparent clearance
|
up to 12 weeks
|
|
Vz/F
大体时间:up to 12 weeks
|
apparent volume of distribution
|
up to 12 weeks
|
|
t1/2
大体时间:up to 12 weeks
|
terminal half-life
|
up to 12 weeks
|
|
body temperature
大体时间: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
大体时间: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
大体时间:up to 12 weeks
|
Evaluate QT interval, PR interval, etc.
|
up to 12 weeks
|
|
adverse events and serious adverse events
大体时间:up to 12 weeks
|
up to 12 weeks
|
|
|
Pulse
大体时间:up to 12 weeks
|
Measure the pulse of the subjects, expressing it in units of beats per minute.
|
up to 12 weeks
|
|
Blood pressure
大体时间:up to 12 weeks
|
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
|
up to 12 weeks
|
合作者和调查者
调查人员
- 首席研究员:YaNan Wang, PHD、The First Hospital of Jilin University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.