A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
NCT ID: NCT06547554
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2024-09-04
2025-10-27
Brief Summary
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Detailed Description
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Cefiderocol is a cephalosporin antibiotic approved in the US for the treatment of complicated urinary tract infections including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Single Dose Cohorts
Administered single fixed dose of Xeruborbactam
Administered single fixed dose of Cefiderocol
Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.
Xeruborbactam
Experimental
Cefiderocol
Experimental
Xeruborbactam/Cefiderocol
A combination of Xeruborbactam and Cefiderocol.
Multiple Dose Cohort Xeruborbactam
Administered multiple fixed doses of Xeruborbactam
Xeruborbactam
Experimental
Multiple Dose Cohort Cefiderocol
Administered multiple fixed doses of Cefiderocol
Cefiderocol
Experimental
Multiple Dose Cohort Cefiderocol and Xeruborbactam
Administered multiple fixed doses of a combination of Cefiderocol and Xeruborbactam.
Xeruborbactam/Cefiderocol
A combination of Xeruborbactam and Cefiderocol.
Multiple Dose Cohort Placebo
Administered multiple fixed volumes of a placebo comparator
Dextrose 5% in water
Placebo
Single Dose Cohorts Placebo
Administered single fixed volume of a placebo comparator
Dextrose 5% in water
Placebo
Interventions
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Xeruborbactam
Experimental
Cefiderocol
Experimental
Xeruborbactam/Cefiderocol
A combination of Xeruborbactam and Cefiderocol.
Dextrose 5% in water
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≥ 18.5 and 32 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
* Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
* Voluntary consent to participate in the study.
Exclusion Criteria
* A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
* Females who are pregnant or lactating
* Documented hypersensitivity reaction or anaphylaxis to any medication. History of any severe hypersensitivity, anaphylaxis, or allergic reaction to cefiderocol or any other beta-lactam antibacterial drugs, or any other excipients used in the formulation (eg, cephalosporins, penicillins, carbapenems, or monobactams)
18 Years
55 Years
ALL
Yes
Sponsors
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Shionogi Inc.
INDUSTRY
Biomedical Advanced Research and Development Authority
FED
Qpex Biopharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Minneapolis Clinic
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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QPEX-400
Identifier Type: -
Identifier Source: org_study_id
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