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.
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).
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).
Parallel
MDR-001
DrugParticipants receive a single oral dose of MDR-001
Primary pharmacokinetic (PK) parameters of MDR-001
Maximum observed plasma concentration (Cmax) of MDR-001 following a single oral dose.
Primary pharmacokinetic (PK) parameters of MDR-001
Area under the plasma concentration curve from time 0 to the last quantifiable concentration (AUC0-t) MDR-001 following a single dose
Primary pharmacokinetic (PK) parameters of MDR-001
Area under the plasma concentration time curve from time 0 to infinity (AUC 0-∞) of MDR-001 following a single dose
Secondary pharmacokinetic parameters
Time to peak concentration (Tmax)
Secondary pharmacokinetic parameters
Terminal elimination half-life (t1/2)
Secondary pharmacokinetic parameters
Clearance (CL/F),
Secondary pharmacokinetic parameters
Apparent volume of distribution (Vz/F)
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