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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Participants receive a single oral dose of MDR-001
The First Hospital of Jilin University
Changchun, Jilin, China
Primary pharmacokinetic (PK) parameters of MDR-001
Maximum observed plasma concentration (Cmax) of MDR-001 following a single oral dose.
Time frame: 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
Time frame: 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
Time frame: 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
Time to peak concentration (Tmax)
Time frame: 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
Terminal elimination half-life (t1/2)
Time frame: 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
Clearance (CL/F),
Time frame: 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
Apparent volume of distribution (Vz/F)
Time frame: 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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