A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Bacterial Infections

In brief

A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Key facts

Study ID: NCT06547554
Run by: Qpex Biopharma, Inc.
People needed: 60
Starts: 2024-09-04
Expected to finish: 2025-10-27
Last updated by the study team: 2025-11-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female, 18 to 55 years of age (inclusive) at the time of signing the informed consent.
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.

You may not qualify if…

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
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)

Where it is running

Minneapolis Clinic — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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