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OpenTrials
Completed

NCT Number: NCT06665555

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

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.

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Key information

Conditions

Pharmacokinetics Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pulmonary Associates

Phoenix, Arizona, 85032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ledaborbactam etzadroxil

Drug

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

Ceftibuten

Drug

Five doses of ceftibuten will be administered orally every 12 hours

Primary outcomes

  1. Intrapulmonary PK - AUC0-12 (ceftibuten)

    Time frame: 0-12 hours after 5th dose

    Area under the curve from time zero to 12 hours

  2. Intrapulmonary PK - AUC0-12 (ledaborbactam)

    Time frame: 0-12 hours after 5th dose

    Area under the curve from time zero to 12 hours

  3. Plasma PK - Cmax (ceftibuten)

    Time frame: 0-12 hours after 5th dose

    Maximum concentration

  4. Plasma PK - Cmax (ledaborbactam)

    Time frame: 0-12 hours after 5th dose

    Maximum concentration

  5. Plasma PK - AUC0-12 (ceftibuten)

    Time frame: Time Frame: 0-12 hours after 5th dose

    Area under the curve from time zero to 12 hours

  6. Plasma PK - AUC0-12 (ledaborbactam)

    Time frame: 0-12 hours after 5th dose

    Area under the curve from time zero to 12 hours

  7. Ratios of drug exposure in ELF to plasma using the AUC values for each matrix

    Time frame: 0-12 hours after 5th dose

Secondary outcomes

  1. Proportion of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Day 1 - Day 8

  2. Proportion of participants discontinuing study drug due to TEAEs and SAEs

    Time frame: Day 1 - Day 8

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

A Phase 1, Open-label Study to Evaluate the Safety and Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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