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This is an open-label, non-randomized study to assess how VCT220 is absorbed, distributed, metabolized, and eliminated after a single oral dose. The study includes three groups: subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), and healthy subjects matched by gender, age, and body mass index (BMI). It will also explore the relationship between baseline liver function measures and the pharmacokinetic (PK) parameters of VCT220, to support appropriate dosing recommendations for patients with liver impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects with mild hepatic impairment (Child-Pugh Class A, score of 5-6) |
|
| Group B | Experimental | Subjects with moderate hepatic impairment (Child-Pugh Class B, score of 7-9) |
|
| Group C | Placebo Comparator | Subjects with normal hepatic function matched to hepatic impairment subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCT220 | Drug | Small molecule GLP-1RA tablet, film coated |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of VCT220 | Predose up to 72 hours postdose (D1 to D4) | |
| Area Under the Serum Concentration Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of VCT220 | Predose up to 72 hours postdose (D1 to D4) | |
| Area Under the Serum Concentration Curve From Time 0 to Infinity(AUC0-inf) of VCT220 | Predose up to 72 hours postdose (D1 to D4) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation endpoints | Including the incidence and severity of AEs and SAEs. | From Day 1 to Day 10 |
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Inclusion Criteria:
For subjects with hepatic impairment, the following additional inclusion criteria must be met:
Exclusion Criteria:
Additional exclusion criteria for subjects with liver dysfunction (exclude if any one condition is met):
Additional exclusion criteria for subjects with normal liver function (exclude if any one condition is met):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo |
| Drug |
VCT220 Placebo tablet |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |