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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Intrapulmonary PK - AUC0-12 (ceftibuten)
Timeframe: 0-12 hours after 5th dose
Intrapulmonary PK - AUC0-12 (ledaborbactam)
Timeframe: 0-12 hours after 5th dose
Plasma PK - Cmax (ceftibuten)
Timeframe: 0-12 hours after 5th dose
Plasma PK - Cmax (ledaborbactam)
Timeframe: 0-12 hours after 5th dose
Plasma PK - AUC0-12 (ceftibuten)
Timeframe: Time Frame: 0-12 hours after 5th dose
Plasma PK - AUC0-12 (ledaborbactam)
Timeframe: 0-12 hours after 5th dose
Ratios of drug exposure in ELF to plasma using the AUC values for each matrix
Timeframe: 0-12 hours after 5th dose