Clinical trial NCT06665555: Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age
Official title: A Phase 1, Open-label Study to Evaluate the Safety and Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Healthy Volunteers
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-10-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Intrapulmonary PK - AUC0-12 (ceftibuten)
timeFrame: 0-12 hours after 5th dose
measure: Intrapulmonary PK - AUC0-12 (ledaborbactam)
timeFrame: 0-12 hours after 5th dose
measure: Plasma PK - Cmax (ceftibuten)
timeFrame: 0-12 hours after 5th dose
measure: Plasma PK - Cmax (ledaborbactam)
timeFrame: 0-12 hours after 5th dose
measure: Plasma PK - AUC0-12 (ceftibuten)
timeFrame: Time Frame: 0-12 hours after 5th dose
measure: Plasma PK - AUC0-12 (ledaborbactam)
timeFrame: 0-12 hours after 5th dose
measure: Ratios of drug exposure in ELF to plasma using the AUC values for each matrix
timeFrame: 0-12 hours after 5th dose
Secondary outcomes:
measure: Proportion of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: Day 1 - Day 8
measure: Proportion of participants discontinuing study drug due to TEAEs and SAEs
timeFrame: Day 1 - Day 8
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
Study officials:
affiliation: Venatorx Pharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: