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NCT04951505 · ClinicalTrials.gov registry record · Phase 1
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
A Phase 1 study, sponsored by Venatorx Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04951505: Completed Phase 1 study, sponsored by Venatorx Pharmaceuticals.
NCT04951505 is a Phase 1 study that has completed, run by Venatorx Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04951505, a Phase 1 study, has completed, sponsored by Venatorx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.
Primary Outcome
Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF)
Interventions
- DRUG cefepime-taniborbactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2021-09-27 |
| Phase | Phase 1 |
What the finished NCT04951505 record still lists
NCT04951505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which cefepime-taniborbactam is the first listed.
NCT04951505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04951505 about?
NCT04951505 is a clinical study titled "Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects". This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intrave...
What is the current status of trial NCT04951505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-06-29. Estimated completion is 2021-09-27.
What interventions are being tested in trial NCT04951505?
The interventions under investigation include: cefepime-taniborbactam (DRUG).
Who is sponsoring clinical trial NCT04951505?
This trial is sponsored by Venatorx Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04951505's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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