A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment

NCT07104162 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Qpex-401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants with Renal Impairment

Conditions

Bacterial Infections

Keywords

beta-lactamase inhibitor

Outcome Measures

Primary Outcomes (7)

• Incidence of treatment-emergent adverse events (TEAEs) by participant and by group

  Number of participants with treatment-emergent adverse events by severity and relationship to treatment

  11-22 days (+/- 2)

• Number of participants with changes from baseline in safety parameters

  Number of participants with changes in safety parameters before and after dosing by subject and group

  11-22 days (+/- 2)

• Maximum plasma concentration measurements by subject and by group (Cmax)

  Comparison will be performed between the groups for maximum plasma concentration (Cmax).

  11-22 days (+/- 2)

• Time to maximum plasma concentration (Tmax)

  Comparison will be performed between the groups for time to maximum plasma concentration (Tmax)

  11-22 days (+/- 2)

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

  Comparison will be performed between the groups for area under the plasma concentration versus time curve (AUC)

  11-22 days (+/- 2)

• Cumulative amount of drug excreted as unchanged in the urine (Aeu)

  This parameter will not be estimated in Group 5

  11-22 days (+/- 2)

• Cumulative amount of drug excreted as unchanged in the dialysate (Aed)

  This parameter will be estimated only in Group 5. Urine pharmacokinetic (PK) parameters will be calculated from urinary excretion and dialysate data.

  11-22 days (+/- 2)

Study Arms (1)

Open Label, Single Dose of IV Cefiderocol/Xeruborbactam

EXPERIMENTAL

Approximately 40 participants will be enrolled in total. Eight participants will be enrolled in each group (G) based on renal impairment (RI) determined by estimated glomerular function rate (eGFR) or need for intermittent hemodialysis (IHD) at screening: * G1: Mild RI (eGFR 60 \< 90 mL/min calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration equation \[CKP-EPI\]) adjusted for the participant's body surface \[BSA\]) * G2: Moderate RI (eGFR 30 to \< 60 mL/min calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA) * G3: Severe RI (eGFR \< 30 mL/min calculated using the 2021 CKD-EPI equation) not receiving IHD therapy * G4: Healthy participants with normal renal function matched to participants in Groups 1 and 2 (Group 3 may be included) based on age, gender and body mass index (BMI) * G5: Participants with end stage renal disease (ESRD) receiving IHD All participants will receive a single dose of cefiderocol/xeruborbactam on Day 1.

Drug: Cefiderocol/Xeruborbactam

Interventions

Cefiderocol/Xeruborbactam DRUG

A fixed dose combination of intravenous cefiderocol and intravenous xeruborbactam

Also known as: Cefiderocol/QPX7728, S-649228

Open Label, Single Dose of IV Cefiderocol/Xeruborbactam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An individual will be eligible to be included in the study only if all of the following criteria apply:
• All participants
• Able to understand the study conduct and tasks required of the participants, sign the informed consent form and willing to cooperate with all tests and examinations required by the protocol.
• Aged 18 to 80 years, inclusive, at the time of consent.
• If female of childbearing potential, must either be sexually abstinent for 14 days prior to Day -1 and remain so through 30 days following dosing of the study intervention or have been using (or agree to use) 2 acceptable methods of birth control when engaging in heterosexual activity
• If female of childbearing potential, must agree not to donate eggs (ova, oocytes) for the purpose of reproduction from Day -1 through 30 days following the last administration of the study intervention.
• If female of non-childbearing potential, must either be postmenopausal (defined as 12 months spontaneous amenorrhea) with serum follicle stimulating hormone (FSH) level in the laboratory-defined postmenopausal range or have undergone sterilization procedures at least 6 months prior to Day -1; documentation of sterilization procedure must be obtained
• Has a BMI ≥ 18.5 kg/m2 and ≤ 45 kg/m2, inclusive.
• Has negative test results for hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, and SARS-CoV-2.
• Participants with normal renal function:
• Has an eGFR ≥ 90 mL/min calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA at screening
• Meets matching criteria for age, BMI, and gender of pooled renally impaired participants as defined in the protocol.
• Participants with renal impairment
• Stable mild to severe renal impairment, as assessed by eGFR calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA at screening
• Is on a stable medication regimen

You may not qualify if:

• Has unstable or new medical condition(s)
• Has had surgery under general anesthesia within the past 3 months prior to Day -1, determined by the investigator to be clinically relevant.
• Documented hypersensitivity reaction or anaphylaxis to any medication.
• History of seizures, convulsions
• Current evidence or history of malignancy
• If female, is pregnant, lactating, or has a positive pregnancy test at screening or Day -1.
• Received any investigational drug within 30 days or 5 half-lives, whichever is longer, of Day -1 for the current clinical study.
• Blood donation or significant blood loss (ie, \> 500 mL) within 56 days prior to Day -1.
• Plasma or platelet donation within 14 days prior to Day -1.
• Any acute illness requiring antibiotic drug therapy within 30 days prior to Day -1 or a febrile illness within 7 days prior to Day -1.
• Vigorous exercise from 72 hours prior to Day -1 through the final FU/EOS Visit.
• Positive drug test at the Screening Visit or Day -1
• Positive alcohol test at screening or Day -1 and/or recent history (ie, within 6 months prior to Day -1) of excessive alcohol intake.
• Concurrent use of medications known to affect the elimination of serum creatinine and competitors of renal tubular secretion
• Employees of the investigative site involved in this study.

Sponsors & Collaborators

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

Study Sites (2)

University of Miami Clinical Pharmacology

Miami, Florida, 33136, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Interventions

Cefiderocol; QPX7728

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

Study Officials

• Thomas Marbury, MD

  Orlando Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Richard Preston, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grigor Mamikonyan, PharmD,PhD

CONTACT

(954) 404-8068; gmamikonyan@clinartis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single-dose

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)