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

NCT06665555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

DRUG

ledaborbactam etzadroxil

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

DRUG

ceftibuten

Five doses of ceftibuten will be administered orally every 12 hours

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Kamal Hamed, MD · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2025-03-13
Completion
2025-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06665555 on ClinicalTrials.gov