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

NCT07550634 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-24

No results posted yet for this study

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)

Interventions

DRUG

MDR-001

Participants receive a single oral dose of MDR-001

Sponsors & Collaborators

  • MindRank AI Ltd

    lead INDUSTRY

Principal Investigators

  • Hong Zhang, MD · The First Hospital of Jilin University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-07-08
Completion
2026-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07550634 on ClinicalTrials.gov