RECRUITING

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

Conditions

Bacterial Infections beta-lactamase inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-09-16

Study Completion:2026-12-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07104162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 male, agrees to be sexually abstinent or agrees to use 2 approved methods of contraception (refer to Inclusion Criterion 4) when engaging in heterosexual activity from Day -1 through 90 days following the last administration of the study intervention, and to not donate sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary. * 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. * 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. * 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 * Receiving stable IHD at least 3 times a week for at least 3 months, using an arteriovenous fistula, graft, or catheter * Is on a stable medication regimen	* Has unstable or new medical condition(s) * Has had major 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. * Unable or unwilling to adhere to the study-specified procedures and restrictions. * QTcF interval \> 500 msec, previous history or family history of prolonged QT syndrome at screening or Day -1. * Use of products containing alcohol, caffeine, xanthine, or ephedrine within 24 hours prior to Day -1; use of alcohol 48 hours prior to Day -1; use of proton pump inhibitors (eg, omeprazole and pantoprazole) 7 days prior to Day -1, including both over-the-counter (OTC) and prescription drugs in these categories; or consumption of grapefruit/grapefruit juice, Seville oranges, pomelo, exotic citrus fruits or grapefruit hybrids or juices containing such products within 7 days prior to Day -1. * Has any clinically significant abnormalities in laboratory values at screening or Day -1, defined in the study protocol. * Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per Investigator discretion. Participants in the renal impairment group will have consideration for the degree of renal impairment and presence of comorbidities. * Has renal disease secondary to hepatic disease (hepatorenal syndrome)

Inclusion Criteria

Exclusion Criteria

* 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 male, agrees to be sexually abstinent or agrees to use 2 approved methods of contraception (refer to Inclusion Criterion 4) when engaging in heterosexual activity from Day -1 through 90 days following the last administration of the study intervention, and to not donate sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary.
* 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.
* 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.
* 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
* Receiving stable IHD at least 3 times a week for at least 3 months, using an arteriovenous fistula, graft, or catheter
* Is on a stable medication regimen

* Has unstable or new medical condition(s)
* Has had major 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.
* Unable or unwilling to adhere to the study-specified procedures and restrictions.
* QTcF interval \> 500 msec, previous history or family history of prolonged QT syndrome at screening or Day -1.
* Use of products containing alcohol, caffeine, xanthine, or ephedrine within 24 hours prior to Day -1; use of alcohol 48 hours prior to Day -1; use of proton pump inhibitors (eg, omeprazole and pantoprazole) 7 days prior to Day -1, including both over-the-counter (OTC) and prescription drugs in these categories; or consumption of grapefruit/grapefruit juice, Seville oranges, pomelo, exotic citrus fruits or grapefruit hybrids or juices containing such products within 7 days prior to Day -1.
* Has any clinically significant abnormalities in laboratory values at screening or Day -1, defined in the study protocol.
* Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per Investigator discretion. Participants in the renal impairment group will have consideration for the degree of renal impairment and presence of comorbidities.
* Has renal disease secondary to hepatic disease (hepatorenal syndrome)

Contacts and Locations

Study Contact

Grigor Mamikonyan, PharmD,PhD

CONTACT

(954) 404-8068

gmamikonyan@clinartis.com

Principal Investigator

Thomas Marbury, MD

PRINCIPAL_INVESTIGATOR

Orlando Clinical Research Center

Richard Preston, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami Clinical Pharmacology

Miami, Florida, 33136

United States

Orlando Clinical Research Center

Orlando, Florida, 32809

United States

Collaborators and Investigators

Sponsor: Qpex Biopharma, Inc.

Thomas Marbury, MD, PRINCIPAL_INVESTIGATOR, Orlando Clinical Research Center
Richard Preston, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-16

Study Completion Date2026-12-23

Study Record Updates

Study Start Date2025-09-16

Study Completion Date2026-12-23

Terms related to this study

Keywords Provided by Researchers

beta-lactamase inhibitor

Additional Relevant MeSH Terms

Bacterial Infections