Study S002550

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

ClinicalTrials.gov record

Registration

Registration: NCT07550634
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: NOT_YET_RECRUITING
Enrollment: 32
Start: 2026-06-01
Primary completion: 2026-07-08
Lead sponsor: MindRank AI Ltd
Conditions: Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B); Hepatic Insufficiency (MeSH ID: D048550)
Interventions: DRUG:MDR-001
Results posted: FALSE

Registered primary outcomes

Primary pharmacokinetic (PK) parameters of MDR-001 [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).]

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