Skip to main content
OpenTrials
Completed

NCT Number: NCT06547554

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Minneapolis Clinic

Minneapolis, Minnesota, 55114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Xeruborbactam

Drug

Experimental

Other names: QPX7728

Cefiderocol

Drug

Experimental

Xeruborbactam/Cefiderocol

Drug

A combination of Xeruborbactam and Cefiderocol.

Dextrose 5% in water

Drug

Placebo

Primary outcomes

  1. The incidence and nature of treatment emergent adverse events (TEAE)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  2. Number of patients with changes from baseline in safety parameters

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  3. Maximum plasma concentration (Cmax)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  4. Time to maximum plasma concentration (Tmax)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  5. Area under the plasma concentration versus time curve (AUC)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  6. Terminal elimination half-life (t1/2,z)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  7. Terminal elimination rate constant (λz)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  8. Total clearance (CL)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  9. Renal clearance (CLR)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

  10. Fraction of dose excreted in urine (Feu)

    Time frame: up to day 17 or up to day 21

    Summarized by cohort

Sponsors and collaborators

Lead sponsor

Qpex Biopharma, Inc.

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority
  • Shionogi Inc.

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.