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Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
NCT06733675 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.
Conditions Studied
Interventions
- DRUG Esomeprazole
- DRUG Ledaborbactam etzadroxil
- DRUG Ceftibuten
- DRUG Ceftibuten-ledaborbactam etzadroxil
Study Locations (1)
Kansas
- ICON, Clinical Research Phase I Unit — Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2025-01-07 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06733675
The ClinicalTrials.gov registry entry for NCT06733675 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Basilea Pharmaceutica, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions — of which Esomeprazole is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06733675 reports 1 study location spanning 1 distinct geographic area — top geographies include Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06733675 about?
NCT06733675 is a clinical study titled "Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination". This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants ...
What is the current status of trial NCT06733675?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2025-01-07. Estimated completion is 2026-06-30.
What conditions does trial NCT06733675 study?
This clinical trial studies the following conditions: Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI), FDC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06733675?
The interventions under investigation include: Esomeprazole (DRUG), Ledaborbactam etzadroxil (DRUG), Ceftibuten (DRUG), Ceftibuten-ledaborbactam etzadroxil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06733675?
This trial is sponsored by Basilea Pharmaceutica, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06733675 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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