drugset / Trial / NCT06157242
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
Phase 1
Completed
32 enrolled
Qpex Biopharma, Inc.
Biomedical Advanced Research and Development Authority · collabShionogi · collab
NaSequentialOpen-labelTreatment
Summary
A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of ORAvance (ceftibuten/xeruborbactam oral prodrug \[QPX7831\]) in participants with renal impairment
Timeline
- Start
- 2024-11-10
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceftibuten | Small molecule | — | Oral |
| Subject | Xeruborbactam | Small molecule | — | Oral |