NCT05789342

A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers

A Four-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-drug Interactions (DDIs) Between GP681 and Rosuvastatin/Digoxin/Itraconazole/Oseltamivir in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a four-part, single-center, Open label phase I clinical study to characterize the DDIs potential of GP681 With Rosuvastatin, Digoxin, Itraconazole or Oseltamivir in Chinese healthy volunteers. This study also aims to evaluate the safety and tolerability of GP681 in the presence of Rosuvastatin, Digoxin, Itraconazole, or Oseltamivir.

Detailed description

GP681 is a potent polymerase acidic (PA) protein endonuclease inhibitor. This study will be run in four parts to characterize the DDIs potential of GP681 with the expected concomitant drugs (Rosuvastatin, Digoxin, Itraconazole, Oseltamivir) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period, and a follow-up telephone call for safety.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GP681	GP681, tablet, oral
DRUG	Rosuvastatin	Rosuvastatin, tablet, oral
DRUG	Digoxin	Digoxin, tablet, oral
DRUG	Itraconazole	Itraconazole, capsule, oral
DRUG	Oseltamivir	Oseltamivir, capsule, oral

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-09-11
• Completion: 2023-10-31
• First posted: 2023-03-29
• Last updated: 2023-11-14

Locations

1 site across 1 country: China