NCT05826249

Safety and Pharmacokinetics of SIM0417 Combined With Ritonavir in Healthy Elderly Subjects

A Single Center, Non-randomized, Open-label Phase I Study to Investigate the Pharmacokinetics and Safety of SIM0417/Ritonavir After Single Dose Administration in Healthy Elderly Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This is a non-randomized, open-label, single-dose, Phase I clinical study and plans to enroll 12-20 healthy elderly subjects aged 65 and above, including 3-6 subjects aged 75 and above, both men and women.

Detailed description

Each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single-dose administration, and ritonavir is administered 12 hours before SIM0417 administration (-12hours), at the time of SIM0417 administration (0hour) and 12hours (12hours), SIM0417 is administered under fasting condition, ritonavir is administered under fasting condition either after meal. The dose of SIM0417 is 750 mg, and the dose of ritonavir is 100 mg.

Conditions

• Elder

Interventions

Type	Name	Description
DRUG	SIM0417/Ritonavir	Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir.

Timeline

• Start date: 2023-04-07
• Primary completion: 2023-09-30
• Completion: 2023-11-30
• First posted: 2023-04-24
• Last updated: 2023-04-24

Locations

1 site across 1 country: China