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NCT06665555 · ClinicalTrials.gov registry record · Phase 1
Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age
A Phase 1 study, sponsored by Basilea Pharmaceutica.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT06665555 is a Phase 1 study that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 34 participants.
The verdict
NCT06665555, a Phase 1 study, has completed, sponsored by Basilea Pharmaceutica.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, single-center PK study in healthy adult male and female participants between 18 and 55 years of age (both inclusive). Thirty-one participants will each undergo one standard bronchoscopy with bronchoalveolar lavage (BAL) following the fifth dose of ceftibuten-ledaborbactam etzadroxil or ceftibuten alone. BAL fluid samples and plasma samples will be collected at designated timepoints to determine the concentrations of ceftibuten, ledaborbactam, and urea.
Interventions
- DRUG ledaborbactam etzadroxil
- DRUG ceftibuten
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2025-03-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06665555
The ClinicalTrials.gov registry entry for NCT06665555 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Basilea Pharmaceutica, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ledaborbactam etzadroxil is the first listed.
NCT06665555 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06665555 about?
NCT06665555 is a clinical study titled "Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age". This is a Phase 1, open-label, single-center PK study in healthy adult male and female participants between 18 and 55 years of age (both inclusive). Thirty-one participants will each undergo one standard bronchoscopy with bronchoalveolar lavage (BAL) following the fifth dose of ceftibuten-ledaborbac...
What is the current status of trial NCT06665555?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2024-11-04. Estimated completion is 2025-03-17.
What interventions are being tested in trial NCT06665555?
The interventions under investigation include: ledaborbactam etzadroxil (DRUG), ceftibuten (DRUG).
Who is sponsoring clinical trial NCT06665555?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
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