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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: Completed Phase 1 study of Bacterial Infections, sponsored by Qpex Biopharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Number of patients with Treatment-Emergent Adverse Events by subject, by group, severity and relationship to treatment
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 |
What the finished NCT06157242 record still lists
NCT06157242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 139-participant average among 17 other Bacterial Infections trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Bacterial Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06157242's enrollment target sits among peer trials
32 14th of 17 higher than 4 of 17 other Bacterial Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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