Bacterial Infections
Conditions
Keywords
beta-lactamase inhibitor
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.
Interventions
DRUGXeruborbactam
Experimental
DRUGCefiderocol
Experimental
DRUGXeruborbactam/Cefiderocol
A combination of Xeruborbactam and Cefiderocol.
Placebo
Sponsors
Shionogi Inc.
Biomedical Advanced Research and Development Authority
Qpex Biopharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, Double-Blind, Controlled, Crossover, Ascending Single Dose Design and Randomized, Double-Blind, Controlled, Multiple Dose Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and nature of treatment emergent adverse events (TEAE) | up to day 17 or up to day 21 | Summarized by cohort |
| Number of patients with changes from baseline in safety parameters | up to day 17 or up to day 21 | Summarized by cohort |
| Maximum plasma concentration (Cmax) | up to day 17 or up to day 21 | Summarized by cohort |
| Time to maximum plasma concentration (Tmax) | up to day 17 or up to day 21 | Summarized by cohort |
| Area under the plasma concentration versus time curve (AUC) | up to day 17 or up to day 21 | Summarized by cohort |
| Terminal elimination half-life (t1/2,z) | up to day 17 or up to day 21 | Summarized by cohort |
| Terminal elimination rate constant (λz) | up to day 17 or up to day 21 | Summarized by cohort |
| Total clearance (CL) | up to day 17 or up to day 21 | Summarized by cohort |
| Renal clearance (CLR) | up to day 17 or up to day 21 | Summarized by cohort |
| Fraction of dose excreted in urine (Feu) | up to day 17 or up to day 21 | Summarized by cohort |
Countries
United States
Outcome results
None listed