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NCT06157242 · ClinicalTrials.gov registry record · Phase 1
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
A Phase 1 study of Bacterial Infections, sponsored by Qpex Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT06157242 is a Phase 1 study of Bacterial Infections that has completed, run by Qpex Biopharma. The registered enrollment target is 32 participants, below the 139-participant average among 17 other Bacterial Infections trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06157242, a Phase 1 study of Bacterial Infections, has completed, sponsored by Qpex Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Ceftibuten
- DRUG Xeruborbactam Oral Prodrug
Study Locations (2)
Florida
- University of Miami Clinical Pharmacology - Miami
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2024-11-10 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06157242
The ClinicalTrials.gov registry entry for NCT06157242 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 17 other Bacterial Infections trials with a reported enrollment target (77% lower). The listed sponsor is Qpex Biopharma, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bacterial Infections appearing as the primary indexed condition, and to 2 interventions - of which Ceftibuten is the first listed.
NCT06157242 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06157242 about?
NCT06157242 is a clinical study titled "PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment". 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
What is the current status of trial NCT06157242?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2024-11-10. Estimated completion is 2025-03-31.
What conditions does trial NCT06157242 study?
This clinical trial studies the following conditions: Bacterial Infections.
What interventions are being tested in trial NCT06157242?
The interventions under investigation include: Ceftibuten (DRUG), Xeruborbactam Oral Prodrug (DRUG).
Who is sponsoring clinical trial NCT06157242?
This trial is sponsored by Qpex Biopharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06157242 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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