Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Fe… (NCT06665555) | Clinical Trial Compass
CompletedPhase 1
Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age
United States34 participantsStarted 2024-11-04
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intrapulmonary PK - AUC0-12 (ceftibuten)
Timeframe: 0-12 hours after 5th dose
2
Intrapulmonary PK - AUC0-12 (ledaborbactam)
Timeframe: 0-12 hours after 5th dose
3
Plasma PK - Cmax (ceftibuten)
Timeframe: 0-12 hours after 5th dose
4
Plasma PK - Cmax (ledaborbactam)
Timeframe: 0-12 hours after 5th dose
5
Plasma PK - AUC0-12 (ceftibuten)
Timeframe: Time Frame: 0-12 hours after 5th dose
6
Plasma PK - AUC0-12 (ledaborbactam)
Timeframe: 0-12 hours after 5th dose
7
Ratios of drug exposure in ELF to plasma using the AUC values for each matrix