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NOT YET RECRUITING
NCT07550634
PHASE1

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

Sponsor: MindRank AI Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-06-01

Completion Date

2026-10-30

Last Updated

2026-04-24

Healthy Volunteers

Yes

Interventions

DRUG

MDR-001

Participants receive a single oral dose of MDR-001

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China