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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Mild hepatic impairment | Experimental |
| |
| Cohort B: Moderate hepatic impairment | Experimental |
| |
| Cohort C: Matched normal hepatic function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDR-001 | Drug | Participants receive a single oral dose of MDR-001 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary pharmacokinetic parameters | Time to peak concentration (Tmax) | 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guodong Li, PhD | Contact | +86 18968027256 | guodong.li@mindrank.cn | |
| Weixia Li, MD | Contact | +86 15000279084 | weixia.li@mindrank.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang, MD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Terminal elimination half-life (t1/2)
| 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), | 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) | 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). |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |