NCT07550634
尚未招募
1 期
A Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of MDR-001 Tablets in Patients With Mild and Moderate Hepatic Impairment and Matched Participants With Normal Hepatic Function
MindRank AI Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年6月1日最近更新:
适应症Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B)Hepatic Insufficiency (MeSH ID: D048550)
干预措施MDR-001
相关药物MDR-001
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- MindRank AI Ltd
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Primary pharmacokinetic (PK) parameters of MDR-001
概览
简要总结
This is a Phase I, single-center, open-label, parallel-group study. A single oral dose of MDR-001, a GLP-1 receptor agonist, will be administered to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and to matched healthy controls. The study aims to evaluate the pharmacokinetics and safety of MDR-001 in these populations. Primary pharmacokinetic endpoints include AUC and Cmax; safety endpoints include adverse events, vital signs, ECG, and laboratory assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary signed informed consent before any study-related activities, and ability to understand the study procedures and methods, and willingness to strictly comply with the protocol to complete the study.
- •Participants (including their partners) must have no pregnancy plan and voluntarily take effective contraceptive measures from screening until 6 months after study drug administration.
- •Age 18 to 70 years (inclusive), male or female.
- •Male body weight ≥50 kg, female body weight ≥45 kg; body mass index (BMI) between 18 and 32 kg/m² (inclusive).
- •Estimated glomerular filtration rate (eGFR, calculated by CKD-EPI formula) ≥60 mL/min/1.73m².
- •Additional criteria for participants with hepatic impairment:
- •Chronic liver injury caused by primary liver disease (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.).
- •Child-Pugh grade A or B (see Appendix 1); recent liver function and complications stable, no significant deterioration (e.g., abdominal pain, increased ascites, nausea, vomiting, anorexia, fever, or worsening of liver-related laboratory results).
- •Stable medication regimen (including type, dose, or frequency) for the treatment of hepatic impairment, complications, or other concomitant diseases for at least 14 days before study drug administration, with no need for adjustment (diuretics and insulin, etc., excepted); or not taking any such medications.
排除标准
- •Allergic constitution, including severe drug allergy or history of drug anaphylaxis; known allergy to the study drug or any of its components.
- •Screening ECG showing QTcF \>450 msec (males) or \>470 msec (females) (Fridericia correction); personal or family history of long QT syndrome; family history (parents, children, siblings) of sudden death before age 40; and/or personal history of unexplained syncope within 1 year before screening.
- •Dysphagia or any gastrointestinal disease affecting drug absorption, including frequent nausea or vomiting from any cause; active peptic ulcer; constipation.
- •Within 6 months before screening: severe gastrointestinal disease (e.g., active ulcer) or gastrointestinal surgery (except appendectomy, cholecystectomy, or other endoscopic procedures judged not to significantly affect gastrointestinal motility); clinically significant gastric emptying abnormality (e.g., pyloric obstruction, gastroparesis).
- •Any symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment at screening (except hepatitis B or C); history of serious active infection within 1 month before screening.
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or genetic disorders predisposing to medullary thyroid carcinoma.
- •Blood donation or blood loss ≥400 mL within 3 months before screening, or planned blood donation during the study or within 1 month after study completion.
- •Use of another investigational drug within 3 months before screening, or planned participation in another clinical study during this study.
- •Use of CYP3A4 inhibitors/inducers or P-gp inhibitors within 14 days before first dose, or planned use during the study.
- •Pregnant or breastfeeding women, or positive pregnancy test.
研究组 & 干预措施
Cohort C: Matched normal hepatic function
Experimental
干预措施: MDR-001 (Drug)
Cohort A: Mild hepatic impairment
Experimental
干预措施: MDR-001 (Drug)
Cohort B: Moderate hepatic impairment
Experimental
干预措施: MDR-001 (Drug)
结局指标
主要结局
Primary pharmacokinetic (PK) parameters of MDR-001
时间窗: Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).
Maximum observed plasma concentration (Cmax) of MDR-001 following a single oral dose.
次要结局
- Secondary pharmacokinetic parameters(Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).)
研究者
研究点 (1)
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