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

NCT06547554 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: QPEX-400
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Bacterial Infections

Keywords

beta-lactamase inhibitor

Outcome Measures

Primary Outcomes (10)

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

  Summarized by cohort

  up to day 17 or up to day 21

• Number of patients with changes from baseline in safety parameters

  Summarized by cohort

  up to day 17 or up to day 21

• Maximum plasma concentration (Cmax)

  Summarized by cohort

  up to day 17 or up to day 21

• Time to maximum plasma concentration (Tmax)

  Summarized by cohort

  up to day 17 or up to day 21

• Area under the plasma concentration versus time curve (AUC)

  Summarized by cohort

  up to day 17 or up to day 21

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

  Summarized by cohort

  up to day 17 or up to day 21

• Terminal elimination rate constant (λz)

  Summarized by cohort

  up to day 17 or up to day 21

• Total clearance (CL)

  Summarized by cohort

  up to day 17 or up to day 21

• Renal clearance (CLR)

  Summarized by cohort

  up to day 17 or up to day 21

• Fraction of dose excreted in urine (Feu)

  Summarized by cohort

  up to day 17 or up to day 21

Study Arms (6)

Single Dose Cohorts

EXPERIMENTAL

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

Drug: Xeruborbactam; Drug: Cefiderocol; Drug: Xeruborbactam/Cefiderocol

Multiple Dose Cohort Xeruborbactam

EXPERIMENTAL

Administered multiple fixed doses of Xeruborbactam

Drug: Xeruborbactam

Multiple Dose Cohort Cefiderocol

EXPERIMENTAL

Administered multiple fixed doses of Cefiderocol

Drug: Cefiderocol

Multiple Dose Cohort Cefiderocol and Xeruborbactam

EXPERIMENTAL

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

Drug: Xeruborbactam/Cefiderocol

Multiple Dose Cohort Placebo

PLACEBO COMPARATOR

Administered multiple fixed volumes of a placebo comparator

Drug: Dextrose 5% in water

Single Dose Cohorts Placebo

PLACEBO COMPARATOR

Administered single fixed volume of a placebo comparator

Drug: Dextrose 5% in water

Interventions

Xeruborbactam DRUG

Experimental

Also known as: QPX7728

Multiple Dose Cohort Xeruborbactam; Single Dose Cohorts

Cefiderocol DRUG

Experimental

Multiple Dose Cohort Cefiderocol; Single Dose Cohorts

Xeruborbactam/Cefiderocol DRUG

A combination of Xeruborbactam and Cefiderocol.

Multiple Dose Cohort Cefiderocol and Xeruborbactam; Single Dose Cohorts

Dextrose 5% in water DRUG

Placebo

Multiple Dose Cohort Placebo; Single Dose Cohorts Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Qpex Biopharma, Inc.: lead
• Shionogi Inc.: collaborator
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Minneapolis Clinic

Minneapolis, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

QPX7728; Cefiderocol; Glucose; Water

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Controlled, Crossover, Ascending Single Dose Design and Randomized, Double-Blind, Controlled, Multiple Dose Design

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 9, 2024
• Study Start: September 4, 2024
• Primary Completion: October 27, 2025
• Study Completion: October 27, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)