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

Basilea Pharmaceutica34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pharmacokinetics Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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