NCT06087055

Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants

An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole With GST-HG171/Ritonavir in Healthy Adult Chinese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Fujian Akeylink Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of GST-HG171/ritonavir in healthy participants.

Conditions

• Healthy Participant

Interventions

Type	Name	Description
DRUG	GST-HG171/Ritonavir	Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3
DRUG	Itraconazole	Administered orally once daily for 9 days from Days 8 through 16
DRUG	GST-HG171/Ritonavir	Administered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14

Timeline

• Start date: 2023-05-12
• Primary completion: 2023-06-05
• Completion: 2023-08-07
• First posted: 2023-10-17
• Last updated: 2023-10-17

Locations

1 site across 1 country: China