Actively Recruiting
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
Led by Qpex Biopharma, Inc. · Updated on 2025-11-25
40
Participants Needed
2
Research Sites
20 weeks
Total Duration
On this page
Sponsors
Q
Qpex Biopharma, Inc.
Lead Sponsor
S
Shionogi Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and pharmacokinetics of a fixed intravenous combination of cefiderocol and xeruborbactam in adults with different levels of stable kidney impairment, including those with end-stage renal disease (ESRD) on intermittent hemodialysis (IHD). This Phase 1, open-label, single-dose study aims to understand how kidney function affects the drug's behavior in the body to help develop dosing recommendations for patients with kidney problems. Participants will receive a single intravenous dose of cefiderocol/xeruborbactam on Day 1. Approximately 40 people will be divided into five groups based on kidney function: mild, moderate, or severe renal impairment, healthy participants with normal kidney function, and those with ESRD receiving IHD. Each group will receive the study drug to assess differences in drug levels and safety. During the study, participants will be monitored for up to 11 to 22 days for any treatment-emergent side effects and changes in safety tests. Researchers will measure drug levels in blood plasma and urine, including the amount removed by dialysis. Participants will undergo clinical exams, laboratory tests, and safety assessments to track the drug's effects and tolerability throughout the follow-up period.
CONDITIONS
Brief Title
A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and willing to cooperate with all tests
- Aged 18 to 80 years at consent
- Males must agree to sexual abstinence or use two contraception methods from Day -1 through 90 days after last dose; no sperm donation during this period
- Females of childbearing potential must be sexually abstinent or use two birth control methods before and after dosing; must not donate eggs during this period
- Females of non-childbearing potential must be postmenopausal or sterilized at least 6 months prior
- Body mass index between 18.5 and 45 kg/m2 inclusive
- Negative tests for hepatitis B, hepatitis C, HIV, and SARS-CoV-2
- Participants with normal renal function: eGFR ≥ 90 mL/min and matched by age, BMI, and gender
- Participants with renal impairment: stable mild to severe impairment and on stable medication
- Participants with ESRD on hemodialysis: stable IHD at least 3 times weekly for 3 months and on stable medication
You will not qualify if you...
- Has unstable or new medical conditions
- Surgery under general anesthesia within 3 months prior to Day -1
- History of hypersensitivity or anaphylaxis to any medication
- History of seizures or convulsions
- Current or past malignancy
- Pregnant, lactating, or positive pregnancy test at screening or Day -1
- Received investigational drug within 30 days or 5 half-lives before Day -1
- Blood donation or significant blood loss (>500 mL) within 56 days prior to Day -1
- Plasma or platelet donation within 14 days prior to Day -1
- Acute illness needing antibiotics within 30 days or fever within 7 days prior to Day -1
- Vigorous exercise from 72 hours before Day -1 through final visit
- Positive drug or alcohol test at screening or Day -1, or recent excessive alcohol intake
- Use of medications affecting serum creatinine elimination or renal tubular secretion
- Employees of the investigative site
- Unable or unwilling to follow study procedures
- QTcF interval > 500 msec or history/family history of prolonged QT syndrome
- Use of alcohol, caffeine, xanthine, ephedrine, proton pump inhibitors, or grapefruit and related citrus products within specified days before Day -1
- Clinically significant abnormalities in lab values at screening or Day -1
- Participants with normal renal function having abnormal physical or lab findings
- Participants with renal impairment having abnormal findings considering renal impairment and comorbidities
- Renal disease secondary to hepatic disease (hepatorenal syndrome)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intravenous dose of the combination drug cefiderocol/xeruborbactam to assess safety and pharmacokinetics in various degrees of renal impairment.
1 dosing visit (in-person) on Day 1
Duration - 11 to 22 days
Participants are monitored for safety and pharmacokinetic outcomes following the single dose of the study drug.
Multiple visits for assessments during this period
Trial Site Locations
Total: 2 locations
1
University of Miami Clinical Pharmacology
Miami, Florida, United States, 33136
Actively Recruiting
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
Research Team
G
Grigor Mamikonyan, PharmD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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