drugset / Trial / NCT05731804
Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | simnotrelvir | Small molecule | 375 mg | — |
| Subject | simnotrelvir | Small molecule | 600 mg | — |
| Subject | simnotrelvir | Small molecule | 750 mg | — |
| Background | Ritonavir | Other / unclassified | 100 mg | — |