Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 21 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03182504
The ClinicalTrials.gov registry entry for NCT03182504 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which meropenem is the first listed.
NCT03182504 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.