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

Basilea Pharmaceutica

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Pharmacokinetics

Treatments: Drug: ceftibuten; Drug: ledaborbactam etzadroxil

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06665555

VNRX-7145-105

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group 1

Experimental group

Description:

Participants in Group 1 will undergo one standardized bronchoscopy with bronchoalveolar lavage after the fifth dose of ceftibuten-ledaborbactam etzadroxil.

Treatment:

Drug: ledaborbactam etzadroxil

Drug: ceftibuten

Group 2

Experimental group

Description:

Participants in Group 2 will undergo one standardized bronchoscopy with bronchoalveolar lavage after the fifth of dose of ceftibuten alone.

Treatment:

Drug: ceftibuten