Hepatic Impairment Clinical Trial
Official title:
A Multicenter, Non-randomized, Open-label, Parallel Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417/Ritonavir After a Single Dose in Subjects With Renal or Hepatic Impairment
This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. It is divided into Part A (subjects with mild/moderate renal impairment and subjects with normal renal function) and Part B (subjects with moderate hepatic impairment and subjects with normal hepatic function).
This is a multicenter, non-randomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. Part A includes 4 cohorts, each of which plans to enroll 6-12 subjects, for a total of 24-48 subjects. Participants will be allocated into normal renal function or mild/moderate renal impairment groups based on their estimated glomerular filtration rate. Part B includes 2 cohorts, each of which plans to enroll 6-12 subjects, for a total of 12-24 subjects. Participants will be allocated into normal hepatic function or moderate hepatic impairment groups based on their Child-Pugh score. Each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single-dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration. ;
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