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

Phase 1 Completed 34 enrolled Basilea Pharmaceutica National Institute of Allergy and Infectious Diseases (NIAID) · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2024-11-04
Primary completion: 2025-03-13
Completion: 2025-03-17

Publications

Rodvold KA, Gotfried MH, de Oliveira CF, Lowe K, Hamed KA, Litherland K, Engelhardt M, McGovern PC. Plasma and intrapulmonary pharmacokinetics of ceftibuten and ledaborbactam in healthy male and female adults. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0195025. doi: 10.1128/aac.01950-25. Epub 2026 Apr 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftibuten	Small molecule	600 mg	Oral
Subject	Ledaborbactam etzadroxil	Small molecule	600 mg	Oral

Indications

No indication recorded.