Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547554
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-controlled Drug-drug Interaction Pharmacokinetic and Safety Study of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase 1 randomized double blind placebo controlled drug-drug interaction pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants
Detailed Description:
Qpex Biopharma Inc is developing xeruborbactam a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases in combination with a beta-lactam antibiotic
Cefiderocol is a cephalosporin antibiotic approved in the US for the treatment of complicated urinary tract infections including pyelonephritis and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
Cefiderocol is a cephalosporin antibiotic approved in the US for the treatment of complicated urinary tract infections including pyelonephritis and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None