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PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment | Clinical Trials | Clareo Health

COMPLETEDPHASE1

PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment

A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of ORAvance (Ceftibuten/Xeruborbactam Oral Prodrug [QPX7831]) in Participants With Renal Impairment

NCT06157242•Qpex Biopharma, Inc.

View on ClinicalTrials.gov

Summary

A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of ORAvance (ceftibuten/xeruborbactam oral prodrug \[QPX7831\]) in participants with renal impairment

Detailed Description

Qpex Biopharma, Inc. is developing an oral dosage form that delivers Xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic. Ceftibuten is a cephalosporin antibiotic approved in the US for acute exacerbations of chronic bronchitis, acute bacterial otitis media and pharyngitis/ tonsillitis. This is a Phase 1 open-label, single-dose study to assess the safety, tolerability, and PK, of ceftibuten and xeruborbactam oral prodrug given in combination to participants with varying degrees of renal impairment as compared to participants with normal renal function. Objectives: The objectives of the study are: 1. To assess the PK of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment. 2. To evaluate the safety and tolerability of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•All Participants:
•1. 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.
•2. Males and females at least 18 years of age, at the time of consent.
•3. If male, agree to be sexually abstinent or to use 2 approved methods of contraception (refer to Inclusion Criterion #4) when engaging in sexual activity from study check-in through 930 days following the last administration of the study intervention, and to refrain from donating sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary.
•4. Females of childbearing potential must either be sexually abstinent for 14 days prior to day 1 and remain so through 30 days following the last administration of the study intervention, OR have been using (or agree to use) 2 acceptable methods of birth control for the times specified:
•1. Intra-uterine device in place for at least 3 months prior to day 1 through 30 days following the final dosing of the study intervention
•2. Barrier method (condom or diaphragm) for at least 14 days prior to day 1 through 30 days following the final dosing of the study intervention
•3. Stable hormonal contraceptive for at least 3 months prior to day 1 through 30 days following final dosing of the study intervention
•4. Surgical sterilization (vasectomy) of partner at least 6 months prior to day 1
•5. Females of non-childbearing potential must either be postmenopausal (defined as 12 months spontaneous amenorrhea) with a serum follicle stimulating hormone (FSH) level in the laboratory defined postmenopausal range or have undergone 1 of the following sterilization procedures detailed in the study protocol at least 6 months prior to day 1:
+15 more criteria

Exclusion Criteria

•All Participants:
•1. Have unstable or new medical conditions (eg, cardiovascular, respiratory, hepatic, renal, gastrointestinal, autoimmune, endocrine, or neurological disorders) which have occurred in the 3 months prior to the first dose of study intervention and which are capable of altering the absorption, distribution, metabolism, or elimination of drugs or, in the opinion of the investigator, constitute a risk factor to participating in the study and/or receiving study intervention.
•2. Documented hypersensitivity reaction or anaphylaxis to any antibiotic including ceftibuten or other beta-lactam antibiotics (eg, cephalosporins, penicillins, carbapenems, or monobactams) or any excipients used in this formulation.
•3. History of clinically significant seizures, head injury, or meningitis.
•4. Current evidence or history of malignancy, except squamous cell carcinoma or basal cell carcinoma of the skin, in the 2 years prior to day -1 with no evidence of recurrence.
•5. Females who are pregnant, lactating, or have a positive pregnancy test at the screening visit or day -1.
•6. Previously received any dose of ORAvance (ceftibuten/xeruborbactam oral prodrug), xeruborbactam oral prodrug, xeruborbactam or prodrug alone.
•7. Received any investigational drug within 30 days or 5 half-lives, whichever is longer, prior to day 1 of the current study.
•8. Blood donation or significant blood loss (ie, \> 500 mL) within 56 days prior to day 1.
•9. Plasma or platelet donation within 14 days prior to day -1.
+18 more criteria

Locations (2)

University of Miami Clinical Pharmacology

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Key Dates

Start Date

November 10, 2024

Primary Completion Date

March 31, 2025

Completion Date

March 31, 2025

Last Updated

May 14, 2025

Enrollment

ACTUAL participants

Conditions

Bacterial Infections

Interventions

Xeruborbactam Oral Prodrug

DRUG

Ceftibuten

DRUG

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Bacterial Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment

Inclusion Criteria

Exclusion Criteria

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