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Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants

Healthy Male Volunteers Clinical Trial

Official title:
A Phase I Study to Investigate The Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants

Clinical Trial Summary

This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral administration of SIM0417 in combination with ritonavir.

Clinical Trial Description

This is a single-center, non-randomized, open-label, single-cohort, single-dose, Phase I clinical study to evaluate the mass balance, biotransformation, safety, and tolerability of SIM0417 following a single oral administration of SIM0417 combination with ritonavir in healthy Chinese adult male subjects. This study is planned to enroll 6-8 healthy male subjects, each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12h), at the time of SIM0417 administration (0h), 12h (12h), and 24h (24h) after SIM0417 administration. SIM0417 is administered after meals, ritonavir is administered either in fasting condition or after meals. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05475834
Study type Interventional
Source Jiangsu Simcere Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date July 21, 2022
Completion date August 7, 2022
View Details
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