Clinical trial NCT06547554: A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Drug-drug Interaction, Pharmacokinetic, and Safety Study of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Bacterial Infections
Keywords: beta-lactamase inhibitor
Lead sponsor: Qpex Biopharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Shionogi Inc.
name: Biomedical Advanced Research and Development Authority
First posted: 2024-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Double-Blind, Controlled, Crossover, ascending single dose design
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Qpex Biopharma, Inc. is developing xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases in combination with a beta-lactam antibiotic.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The incidence and nature of treatment emergent adverse events (TEAE)
timeFrame: 17 days
measure: Number of patients with changes from baseline in safety parameters
timeFrame: 17 days
measure: Peak plasma Concentration measurements by subject and by cohort (Cmax)
timeFrame: 17 days
measure: Time concentration data measurements by subject and by cohort (Tmax)
timeFrame: 17 days
measure: Area under the plasma concentration versus time curve (AUC) between cohorts
timeFrame: 17 days
measure: Urine Pharmacokinetic (PK) amount excreted by subject and by cohort
timeFrame: 17 days
measure: Urine Pharmacokinetic (PK) % dose excreted by subject and by cohort
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Clinic
state: Minnesota
Study officials:
References: