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NCT03182504 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03182504: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03182504 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03182504, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the beta-lactam meropenem for the treatment of serious gram-negative bacterial infections. Adult male and female healthy participants will receive a single intravenous infusion of nacubactam co-administered with meropenem and then undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.
Primary Outcome
The ELF to plasma ratio will be calculated from the concentration of nacubactam in ELF and plasma as a measure of the intrapulmonary penetration of nacubactam in healthy participants.
Interventions
- DRUG meropenem
- DRUG nacubactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-06-15 |
| Est. Completion | 2017-08-10 |
| Phase | Phase 1 |
What the finished NCT03182504 record still lists
NCT03182504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which meropenem is the first listed.
NCT03182504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03182504 about?
NCT03182504 is a clinical study titled "A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants". The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the beta-lactam meropenem for the treatment of serious gram-negative bacterial...
What is the current status of trial NCT03182504?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2017-06-15. Estimated completion is 2017-08-10.
What interventions are being tested in trial NCT03182504?
The interventions under investigation include: meropenem (DRUG), nacubactam (DRUG).
Who is sponsoring clinical trial NCT03182504?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03182504's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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