NCT05928988

A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects

A Phase 1, Open-label, Fixed-sequence Study to Estimate the Effects of Multiple-dose Administration of Itraconazole on the Pharmacokinetics of SHR8554 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SHR8554；Itraconazole	Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm

Timeline

• Start date: 2022-01-04
• Primary completion: 2022-01-21
• Completion: 2022-06-09
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: China