Recruiting
Phase 1

Observational Study

Sponsor:

Basilea Pharmaceutica

Code:

NCT06733675

Conditions

Healthy Volunteer

Pharmacokinetics

Safety

Drug-Drug Interaction (DDI)

FDC

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Ledaborbactam etzadroxil

Ceftibuten

Ceftibuten-ledaborbactam etzadroxil

Esomeprazole

amoxicillin-clavulanate

Study Details

Brief summary:

This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). 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 , 43 days for Part 2 and 83 days for Part 3. All participants in Parts I und 2 will be screened within 28 days prior to dosing. All participants in Part 3 will be screened within 33 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. Participants in Part 3 will also return to the clinic for follow-up assessments 28 days ± 2 days and 42 days ± 2 days after the last dose of study intervention.

Conditions

Healthy Volunteer

Pharmacokinetics

Safety

Drug-Drug Interaction (DDI)

FDC

Study ID

NCT06733675

Start date

Jan 7, 2025

Status verified date

Jul, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1

Part 1 will enroll at least 16 participants who will receive a single oral dose of ceftibuten and ledaborbactam etzadroxil following a 10-hour fast on 3 occasions in a fixed sequence: (a) Ceftibuten and ledaborbactam etzadroxil as separate capsules; (b) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination (FDC) capsules; (c) Ceftibuten-ledaborbactam etzadroxil as FDC capsules after 5 days of esomeprazole orally once daily

experimental: Part 2 Group 1

Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fasted Group)

experimental: Part 2 Group 2

Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fed Group)

experimental: Part 3 (Groups 1, 2, 4, 5, 6)

Part 3 will enroll up to 50 participants. Each will receive oral doses of ceftibuten and/or ledaborbactam etzadroxil capsules (combined as FDC when administered together) in fed conditions

active comparator: Part 3 Group 3

Part 3 Group 3 will enroll up to 10 participants. Each will receive oral doses of amoxicillin-clavulanate

Interventions

Ledaborbactam etzadroxil

capsules

Ceftibuten

capsules

Ceftibuten-ledaborbactam etzadroxil

Fixed Dose Combination (FDC)

Esomeprazole

40 mg capsule

amoxicillin-clavulanate

500 mg-125 mg oral doses

Primary outcome measure

  • Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) [ Time Frame: 0 - 48 hours on days 1, 4 and 11 ]
  • Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) [ Time Frame: 0 - 48 hours on days 1, 4 and 11 ]
  • Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. [ Time Frame: Day 1 thru Day 18 (+/-1) ]
  • Proportion of participants of Part 3 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. [ Time Frame: Day 1 thru Day 49 (± 2 days) ]

Central Contacts and Locations

Central contacts

Karine Litherland, PhD

+41616061111Karine.Litherland@basilea.com

Locations

ICON, Clinical Research Phase I Unit

Recruiting

Lenexa, Kansas, United States, 66219

Contacts

Daniel Dickerson, MD. PhD, FAAFP

913-205-4397Daniel.Dickerson@iconplc.com

Principal Investigator:

Daniel Dickerson, MD, PhD, FAAFP

More Information

Sponsor

Basilea Pharmaceutica

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Healthy Volunteers
  • Ceftibuten
  • Ledaborbactam etzadroxil

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Basilea Pharmaceutica on 2026-07-09.