A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Changchun
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Jilin City, Changchun, 중국, 130000
- The First Hospital of Jilin University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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;
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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실험적: mild hepatic impairment (Child-Pugh A) 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.
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실험적: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cmax
기간: up to 12 weeks
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maximum concentration
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up to 12 weeks
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AUC0-last
기간: up to 12 weeks
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area under the plasma concentration-time curve from 0 to the last quantifiable time point
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up to 12 weeks
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AUC0-inf
기간: up to 12 weeks
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area under the plasma concentration-time curve from 0 to infinity
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up to 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tmax
기간: up to 12 weeks
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time to reach maximum concentration
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up to 12 weeks
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CL/F
기간: up to 12 weeks
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apparent clearance
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up to 12 weeks
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Vz/F
기간: up to 12 weeks
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apparent volume of distribution
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up to 12 weeks
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t1/2
기간: up to 12 weeks
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terminal half-life
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up to 12 weeks
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body temperature
기간: up to 12 weeks
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Measure the body temperature of the subjects, using degrees Celsius as the unit.
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up to 12 weeks
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IU/L or mIU/mL of HCG in the blood of reproductive-aged women
기간: up to 12 weeks
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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
기간: up to 12 weeks
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Evaluate QT interval, PR interval, etc.
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up to 12 weeks
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adverse events and serious adverse events
기간: up to 12 weeks
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up to 12 weeks
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Pulse
기간: up to 12 weeks
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Measure the pulse of the subjects, expressing it in units of beats per minute.
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up to 12 weeks
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Blood pressure
기간: up to 12 weeks
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Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
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up to 12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: YaNan Wang, PHD, The First Hospital of Jilin University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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