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Safety and Drug Levels of Ceftibuten-ledaborbactam Etzadroxil

This study is looking at the safety and how the body handles a new combination medicine called Ceftibuten-ledaborbactam etzadroxil. We are also studying its individual components, Ceftibuten and Ledaborbactam etzadroxil, and how they interact with other common medicines like Esomeprazole and amoxicillin-clavulanate. This is a Phase 1 study, meaning it's an early step to understand the drug better. We plan to enroll about 96 healthy adults between 18 and 55 years old. The main goals are to measure how much of the drugs are in the blood over time and to track any side effects. We are currently recruiting participants for this study.

Study design
This is a Phase 1, open-label study, meaning you and the study team will know which treatment you are receiving. It involves about 96 healthy adult participants and is divided into three parts.
What's involved
Your participation would last approximately 43 to 83 days, depending on which part of the study you join. You would be screened within 28 to 33 days before starting the study.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for about 18 days after your last dose of the study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06733675

Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Basilea Pharmaceutica
~96 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Ledaborbactam etzadroxilCeftibutenCeftibuten-ledaborbactam etzadroxilEsomeprazoleamoxicillin-clavulanate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Measured over 0 - 48 hours on days 1, 4 and 11
+3 more outcomes measured

Conditions

Healthy Volunteer
Pharmacokinetics
Safety
Drug-Drug Interaction (DDI)
FDC

Explore related trials

Healthy Volunteer

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Kamal Hamed, MD · STUDY_DIRECTOR · Basilea Pharmaceutica International Ltd, Allschwil

Who to contact

Karine Litherland, PhD
[email protected]
+41616061111
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Healthy adult male or female, between 18 and 55 years of age
Body mass index ≥ 18 and ≤ 32 kg/m2
Laboratory values meeting defined laboratory ranges
Males or non-pregnant, non-lactating females

Exclusion

History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant
Positive alcohol, drug or tobacco use/test

What this trial measures

  • Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)0 - 48 hours on days 1, 4 and 11

    Area under the concentration time curve from time zero to infinity (AUC0-∞)

  • Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)0 - 48 hours on days 1, 4 and 11

    Maximum observed concentration (Cmax)

  • Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.Day 1 thru Day 18 (+/-1)

    Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.

  • Proportion of participants of Part 3 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.Day 1 thru Day 49 (± 2 days)

    Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.