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NCT05488678 · ClinicalTrials.gov registry record · Phase 1
Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
A Phase 1 study, sponsored by Basilea Pharmaceutica.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05488678: Completed Phase 1 study, sponsored by Basilea Pharmaceutica.
NCT05488678 is a Phase 1 study that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05488678, a Phase 1 study, has completed, sponsored by Basilea Pharmaceutica.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
Primary Outcome
Maximum plasma concentration, determined directly from individual concentration time data
Interventions
- DRUG Ceftibuten
- DRUG VNRX-7145
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-10-12 |
| Est. Completion | 2023-11-23 |
| Phase | Phase 1 |
What the finished NCT05488678 record still lists
NCT05488678 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Ceftibuten is the first listed.
NCT05488678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05488678 about?
NCT05488678 is a clinical study titled "Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function". This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent...
What is the current status of trial NCT05488678?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-10-12. Estimated completion is 2023-11-23.
What interventions are being tested in trial NCT05488678?
The interventions under investigation include: Ceftibuten (DRUG), VNRX-7145 (DRUG).
Who is sponsoring clinical trial NCT05488678?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05488678's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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