Phase 1 Study of Single Oral Dose VC005 Tablets to Assess Safety and Pharmacokinetics in Adults Aged 18 to 70 With and Without Kidney Impairment

What this Trial Is About

This research aims to study the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in adults with varying kidney function. It compares participants with renal impairment to those with normal kidney function to understand how the drug behaves in the body and its safety profile. The trial is a Phase I, open-label study designed to provide early information on the drugs behavior in these groups. Participants receive a single oral dose of 25 mg VC005 tablets during the study. The trial includes several groups based on kidney function normal renal function, mild renal impairment, moderate renal impairment, and severe renal impairment. Each participant receives only one dose, and the study uses a non-randomized, parallel design to compare these groups. During the trial, participants undergo monitoring to measure the drug concentration in their plasma over three days, focusing on the area under the plasma concentration-time curve and the maximum observed plasma concentration. Safety assessments are also conducted. The total participation involves a screening period followed by dosing and observation for up to three days to gather pharmacokinetic and safety data.

Pharmacokinetics of VC005 Tablets in Subjects With Renal Impairment and Normal Renal Function