drugset / Trial / NCT05731804

Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir

NCT05731804

Phase 1 Unknown 72 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2023-03-01
Primary completion
2023-12-01
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject simnotrelvir Small molecule 375 mg
Subject simnotrelvir Small molecule 600 mg
Subject simnotrelvir Small molecule 750 mg
Background Ritonavir Other / unclassified 100 mg