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

Qpex Biopharma

Status and phase: Completed; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: Cefiderocol; Drug: Xeruborbactam/Cefiderocol; Drug: Dextrose 5% in water; Drug: Xeruborbactam

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06547554

QPEX-400

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

60 participants in 6 patient groups, including a placebo group

Single Dose Cohorts

Experimental group

Description:

Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.

Treatment:

Drug: Xeruborbactam

Drug: Xeruborbactam/Cefiderocol

Drug: Cefiderocol

Multiple Dose Cohort Xeruborbactam

Experimental group

Description:

Administered multiple fixed doses of Xeruborbactam

Treatment:

Drug: Xeruborbactam

Multiple Dose Cohort Cefiderocol

Experimental group

Description:

Administered multiple fixed doses of Cefiderocol

Treatment:

Drug: Cefiderocol

Multiple Dose Cohort Cefiderocol and Xeruborbactam

Experimental group

Description:

Administered multiple fixed doses of a combination of Cefiderocol and Xeruborbactam.

Treatment:

Drug: Xeruborbactam/Cefiderocol

Multiple Dose Cohort Placebo

Placebo Comparator group

Description:

Administered multiple fixed volumes of a placebo comparator

Treatment:

Drug: Dextrose 5% in water

Single Dose Cohorts Placebo

Placebo Comparator group

Description:

Administered single fixed volume of a placebo comparator

Treatment:

Drug: Dextrose 5% in water