Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment

NCT07550634 | Not Yet Recruiting Phase 1

• 1 other identifier: MDR-001-CN-07
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B); Hepatic Insufficiency (MeSH ID: D048550)

Keywords

MDR-001; Hepatic impairment (mild, moderate); Child-Pugh A / Child-Pugh B; GLP-1 receptor agonist (GLP-1RA); Pharmacokinetics (PK); safety; Phase I clinical study; Matched healthy controls; Open-label

Outcome Measures

Primary Outcomes (3)

• Primary pharmacokinetic (PK) parameters of MDR-001

  Maximum observed plasma concentration (Cmax) of MDR-001 following a single oral dose.

  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).

• 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

  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).

• 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

  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).

Secondary Outcomes (4)

• 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).

• 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).

• 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).

• 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).

Study Arms (3)

Cohort A: Mild hepatic impairment

EXPERIMENTAL

Drug: MDR-001

Cohort B: Moderate hepatic impairment

EXPERIMENTAL

Drug: MDR-001

Cohort C: Matched normal hepatic function

EXPERIMENTAL

Drug: MDR-001

Interventions

MDR-001 DRUG

Participants receive a single oral dose of MDR-001

Cohort A: Mild hepatic impairment; Cohort B: Moderate hepatic impairment; Cohort C: Matched normal hepatic function

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of depression or other serious mental disorders (e.g., schizophrenia, bipolar disorder, or other severe mood or anxiety disorders); history of suicidal ideation or suicidal behavior.
• Any other reason judged by the investigator as unsuitable for enrollment.

Sponsors & Collaborators

• MindRank AI Ltd: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Hong Zhang, MD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guodong Li, PhD

CONTACT

+86 18968027256; guodong.li@mindrank.cn

Weixia Li, MD

CONTACT

+86 15000279084; weixia.li@mindrank.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 8, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)