Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2021
CompletedStudy Start
First participant enrolled
June 29, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2021
CompletedJune 8, 2025
June 1, 2025
3 months
June 28, 2021
June 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
ELF Cmax
Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF)
0-8 hours after 6th dose
Secondary Outcomes (1)
Number of subjects with adverse events
Day 1 - Day 8
Study Arms (1)
cefepime-taniborbactam
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy adults 18-55 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18 kg/m2 and ≤32.0 kg/m2, weight \>50.0 kg.
- Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study
You may not qualify if:
- History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- Recent history of known or suspected Clostridioides difficile infection
- Abnormal ECG or history of clinically significant abnormal rhythm disorder
- Abnormal lab tests
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pulmonary Associates PA
Phoenix, Arizona, 85032, United States
Related Publications (1)
Rodvold KA, Gotfried MH, Sabato P, Henkel T, McGovern PC. Plasma and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult participants. Antimicrob Agents Chemother. 2025 Jul 2;69(7):e0049325. doi: 10.1128/aac.00493-25. Epub 2025 Jun 6.
PMID: 40476839DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2021
First Posted
July 6, 2021
Study Start
June 29, 2021
Primary Completion
September 27, 2021
Study Completion
September 27, 2021
Last Updated
June 8, 2025
Record last verified: 2025-06