Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789342
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-02-21
Brief Title:
A Study to Evaluate the Drug-drug Interactions DDIs of GP681 With Rosuvastatin Digoxin Itraconazole Oseltamivir in Chinese Healthy Volunteers
Sponsor:
Jiangxi Qingfeng Pharmaceutical Co Ltd
Organization:
Jiangxi Qingfeng Pharmaceutical Co Ltd
Study Overview
Official Title:
A Four-part Single-center Open-label Phase I Clinical Study to Evaluate the Drug-drug Interactions DDIs Between GP681 and RosuvastatinDigoxinItraconazoleOseltamivir in Chinese Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None