Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age

A Phase 1, Open-label Study to Evaluate the Safety and Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adult Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06665555

Enrollment

Registered

2024-10-30

Start date

2024-11-04

Completion date

2025-03-17

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Pharmacokinetics

Brief 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

DRUGledaborbactam etzadroxil

Five doses of ledaborbactam etzadroxil will be administered orally every 12 hours

DRUGceftibuten

Five doses of ceftibuten will be administered orally every 12 hours

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults 18-55 years * Males or non-pregnant, non-lactating females * Body Mass Index: ≥18 and ≤32 kg/m2 * Forced expiratory volume in 1 second of at least 80% of predicted value * Laboratory values meeting defined entry criteria

Exclusion criteria

* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug or to medications used during a bronchoscopy * Conditions that potentially alter absorption and/or excretion of orally administered drugs * History or presence of significant diseases, including any clinically relevant acute illness or surgery within the past 3 months * Positive alcohol, drug, or tobacco use/test

Design outcomes

Primary

Measure	Time frame	Description
Intrapulmonary PK - AUC0-12 (ceftibuten)	0-12 hours after 5th dose	Area under the curve from time zero to 12 hours
Plasma PK - Cmax (ceftibuten)	0-12 hours after 5th dose	Maximum concentration
Plasma PK - Cmax (ledaborbactam)	0-12 hours after 5th dose	Maximum concentration
Plasma PK - AUC0-12 (ceftibuten)	Time Frame: 0-12 hours after 5th dose	Area under the curve from time zero to 12 hours
Plasma PK - AUC0-12 (ledaborbactam)	0-12 hours after 5th dose	Area under the curve from time zero to 12 hours
Ratios of drug exposure in ELF to plasma using the AUC values for each matrix	0-12 hours after 5th dose	—
Intrapulmonary PK - AUC0-12 (ledaborbactam)	0-12 hours after 5th dose	Area under the curve from time zero to 12 hours

Secondary

Measure	Time frame
Proportion of participants discontinuing study drug due to TEAEs and SAEs	Day 1 - Day 8
Proportion of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Day 1 - Day 8

Countries

United States

Contacts

STUDY_DIRECTORKamal Hamed, MD

Basilea Pharmaceutica International Ltd, Allschwil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026