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

Qpex Biopharma, Inc.60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bacterial Infections

Interventions

XeruborbactamDRUG

Experimental

CefiderocolDRUG

Experimental

Xeruborbactam/CefiderocolDRUG

A combination of Xeruborbactam and Cefiderocol.

Dextrose 5% in water

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Minneapolis Clinic

Minneapolis, Minnesota, United States