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

NCT ID: NCT06665555

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2025-03-17

Brief 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.

Conditions

Pharmacokinetics; Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

ledaborbactam etzadroxil

Intervention Type: DRUG

Five doses of ledaborbactam etzadroxil will be administered orally every 12 hours

ceftibuten

Intervention Type: DRUG

Five doses of ceftibuten will be administered orally every 12 hours

Group 2

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

Group Type: EXPERIMENTAL

ceftibuten

Intervention Type: DRUG

Five doses of ceftibuten will be administered orally every 12 hours

Interventions

ledaborbactam etzadroxil

Five doses of ledaborbactam etzadroxil will be administered orally every 12 hours

Intervention Type: DRUG

ceftibuten

Five doses of ceftibuten will be administered orally every 12 hours

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kamal Hamed, MD

Role: STUDY_DIRECTOR

Basilea Pharmaceutica International Ltd, Allschwil

Locations

Pulmonary Associates

Phoenix, Arizona, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

VNRX-7145-105

Identifier Type: -

Identifier Source: org_study_id