Actively Recruiting
A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment
Led by Qpex Biopharma, Inc. · Updated on 2025-11-25
40
Participants Needed
2
Research Sites
66 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
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
Official 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 required tests
- Aged 18 to 80 years inclusive
- If male, agrees to sexual abstinence or use of two approved contraception methods during and 90 days after treatment
- If female of childbearing potential, agrees to sexual abstinence or use of two acceptable birth control methods during and 30 days after treatment
- If female of childbearing potential, agrees not to donate eggs during and 30 days after treatment
- If female of non-childbearing potential, must be postmenopausal or have undergone sterilization 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 must have eGFR ≥ 90 mL/min and match age, BMI, and gender of renally impaired participants
- Participants with renal impairment must have stable mild to severe renal impairment and be on stable medication
- Participants with end-stage renal disease must receive stable intermittent hemodialysis at least 3 times per week and be on stable medication
You will not qualify if you...
- Unstable or new medical conditions
- Surgery under general anesthesia within 3 months prior to study start deemed clinically relevant
- 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
- Received any investigational drug within 30 days or 5 half-lives before study
- Blood donation or significant blood loss (>500 mL) within 56 days prior
- Plasma or platelet donation within 14 days prior
- Acute illness requiring antibiotics within 30 days or febrile illness within 7 days prior
- Vigorous exercise from 72 hours prior through study end
- Positive drug or alcohol test at screening or recent history of excessive alcohol intake
- Use of medications affecting creatinine elimination or renal tubular secretion
- Employment at the investigative site
- Inability or unwillingness 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 certain citrus products within specified times prior to study
- Clinically significant laboratory abnormalities at screening
- Abnormal physical exam or lab findings deemed clinically significant by investigator
- Renal disease caused by liver disease (hepatorenal syndrome)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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