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This Phase 1 study is designed to evaluate the pharmacokinetics and safety of a single oral dose of VCT220 (other name: CX11) in subjects with moderate renal impairment compared with age-, sex-, and body mass index (BMI)-matched subjects with normal renal function. The results of this study will provide scientific evidence to support appropriate clinical dosing recommendations of VCT220 in subjects with renal impairment.
This is a single-center, single-dose, open-label, non-randomized, parallel-group Phase 1 study. Subjects with moderate renal impairment (absolute estimated glomerular filtration rate [eGFR] ≥30 and <60 mL/min) and matched subjects with normal renal function (absolute eGFR ≥90 and <130 mL/min) will be enrolled.
Subjects will receive a single oral dose of VCT220 40 mg following a standardized breakfast. Pharmacokinetic blood samples will be collected up to 72 hours post-dose to characterize the plasma pharmacokinetics of VCT220 and its metabolite VCT289. Safety will be assessed through monitoring of adverse events, vital signs, physical examinations, laboratory tests, and electrocardiograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects with Moderate Renal Impairment (absolute eGFR ≥30 and <60 mL/min) |
|
| Group B | Experimental | Subjects with Normal Renal Function Matched to Subjects with Moderate Renal Impairment (absolute eGFR ≥90 and <130 mL/min) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCT220 | Drug | Single oral dose of VCT220 40 mg administered after a standardized breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of VCT220 | Day 1 at 0 h prior to dosing and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 h (Day 2) ,36.0 h(Day 2) , 48.0 h (Day 3), and 72.0 h (Day 4) after dosing | |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCâ‚€-t) of VCT220 | Day 1 at 0 h prior to dosing and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 h (Day 2) ,36.0 h(Day 2) , 48.0 h (Day 3), and 72.0 h (Day 4) after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From dosing through safety follow-up (Day 7 ± 3 days) |
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Inclusion Criteria:
Absolute eGFR ≥90 and <130 mL/min Matched to moderate renal impairment subjects by sex, age (±10 years), and BMI (±10%)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 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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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |