Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adults (18-55 Years)

This was a Phase 1, open-label, single-center Pharmacokinetic (PK) study to evaluate plasma and intrapulmonary pharmacokinetics (PK) of ceftibuten and ledaborbactam in healthy adult participants. Approximately 31 participants were planned to be enrolled in two groups, with approximately 25 in Group 1 and approximately six in Group 2.

Participants must have met the following key criteria to be eligible for enrollment into the study: 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