Bacterial InfectionsPhase 1NCT06157242
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
A Phase 1 study testing Xeruborbactam Oral Prodrug and Ceftibuten in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Xeruborbactam Oral Prodrug and Ceftibuten
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Males and females at least 18 years of age, at the time of consent.
- 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.
- 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:
- 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
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- 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
- Stable hormonal contraceptive for at least 3 months prior to day 1 through 30 days following final dosing of the study intervention
- Surgical sterilization (vasectomy) of partner at least 6 months prior to day 1
- 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:
- Bilateral tubal ligation
- Hysterectomy
- Hysterectomy with unilateral or bilateral oophorectomy
- Bilateral oophorectomy
- Have a BMI ≥ 18.5 kg/m2 and ≤ 45 kg/m2, inclusive.
- Have sufficient peripheral vascular access, based on the site's assessment, for PK blood sample collection.
- Have a semi-recumbent pulse rate ≥ 45 beats per minute (bpm) and ≤ 110 bpm during the vital sign assessment at the screening visit or day -1.
- Willing to abstain from alcohol for 48 hours prior to dosing through discharge from the phase 1 unit on day 8.
- Participants With Renal Impairment:
- Have an eGFR < 90 mL/min calculated using the CKD-EPI equation adjusted for the participant's BSA and will be calculated using the estimation equation recommended by the FDA. Specifically, group 1, mild renal impairment (eGFR 60 < 90 mL/min); group 2, moderate renal impairment (eGFR 30 to < 60 mL/min); and group 3, severe renal impairment (eGFR < 30 mL/min) not receiving dialysis therapy.
- Have negative test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody and anti-human immunodeficiency virus (HIV) antibody. Participants with renal impairment with a positive HCV antibody result will be included at the investigator's discretion if all liver enzyme parameters are within the normal range.
- Participants With Normal Renal Function:
- Have an eGFR ≥ 90 mL/min calculated using the CKD-EPI equation adjusted for the participant's BSA.
- Have negative test results for HBsAg, anti HCV antibody and anti-HIV antibody.
- Meet matching criteria for age, BMI, and gender of pooled renally impaired as defined in the protocol.
Who cannot join
- All Participants:
- 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.
- 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.
- History of clinically significant seizures, head injury, or meningitis.
- 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.
- Females who are pregnant, lactating, or have a positive pregnancy test at the screening visit or day -1.
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- Previously received any dose of ORAvance (ceftibuten/xeruborbactam oral prodrug), xeruborbactam oral prodrug, xeruborbactam or prodrug alone.
- Received any investigational drug within 30 days or 5 half-lives, whichever is longer, prior to day 1 of the current 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 48 hours prior to day -1 until the day of discharge from the study.
- Positive drug test at the screening visit or day -1 unless results can be explained by a prescription medication and/or recent history (ie, within 6 months prior to day -1) of abuse of prescription or illicit drugs as detailed in the study protocol.
- Positive alcohol test at the screening visit or day -1 and/or recent history (ie, within 6 months prior to day -1) of excessive alcohol intake as defined in the study protocol.
- Excessive intake of alcohol, defined as an average weekly intake of > 14 standard drinks, (standard drink is the equivalent to 120 ml of wine (approximately 12% abv), 350 ml of regular beer (approximately 5% abv), or 45 ml of spirits (40% abv).
- Concurrent use of medications known to affect the elimination of serum creatinine and competitors of renal tubular secretion within 30 days prior to the first dose of study intervention or anticipated need for these therapies through the last PK sample.
- 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 caffeine, xanthine, or ephedrine within 24 hours before dosing; the use of alcohol 48 hours prior to dosing; or antacids including calcium carbonate, H2 receptor blockers, and proton pump inhibitors are prohibited 7 days prior to day 1 until the end of the study, including both over-the-counter (OTC) and prescription drugs in these categories.
- Have any clinically significant abnormalities in laboratory values at screening or check-in (day -1), defined in the study protocol.
- Liver function abnormalities at screening or check-in (day -1) (defined by an elevation in total bilirubin, aspartate aminotransferase (AST), or alanine transaminase (ALT), > upper limit of normal range for participants based on age and sex).
- Participants With Renal Impairment:
- 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.
- Have a semi-recumbent systolic BP > 180 or < 90 mm Hg or have a semi-recumbent diastolic BP > 110 or < 50 mm Hg at the screening visit or day -1.
- Participants With Normal Renal Function:
- Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per investigator discretion.
- Have a semi-recumbent systolic BP > 150 or < 90 mm Hg or have a semi-recumbent diastolic BP > 95 or < 50 mm Hg at the screening visit or day -1.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Clinical Pharmacology
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: 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
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
Read the 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:
- To assess the PK of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment.
- To evaluate the safety and tolerability of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment.
- Conditions
- Bacterial Infections
- Being tested
- Xeruborbactam Oral Prodrug, Ceftibuten
- Keywords
- beta-lactamase inhibitor
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeruborbactam Oral ProdrugDrug
Also called QPX7831
Experimental
CeftibutenDrug
Experimental
| Study group | Role | What they receive |
|---|---|---|
| Open Label, Single Dose Combination of Ceftibuten & Xeruborbactam oral prodrug | Experimental | 24 pts will be enrolled with varying degrees of RI as well as 8 participants with normal renal function (NRF). 8 participants will be enrolled in each group (G) based on estimated glomerular function rate (eGFR) at screening:
* G1: Mild RI (eGFR 60 to 90 mL/min/1.73m2 calculated using the 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/1.73m2 calculated using the CKD-EPI equation adjusted for the participant's BSA)
* G3: Severe RI (eGFR < 30 mL/min/1.73m2 calculated using the CKD-EPI equation) not receiving dialysis therapy
* G4: Healthy participants with NRF matched to patients in Groups 1, 2 and 3 based on age, gender and BMI All pts will receive a single dose of ceftibuten \& QPX7831 on Day 1. Pts will remain in the clinic until completion of the post-dose procedures on Day 8. Participants will be contacted by phone between Days 10-12 for follow-up. Receives: Drug: Xeruborbactam Oral Prodrug; Drug: Ceftibuten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent adverse events by subject and by group
Number of patients with Treatment-Emergent Adverse Events by subject, by group, severity and relationship to treatment
Measured: 10 days
Number of patients with changes from baseline in safety parameters
Number of patients with changes in safety parameters before and after dosing by subject and group
Measured: 10 days
Peak plasma Concentration measurements by subject and by group (Cmax)
Comparison will be performed between the groups for concentration measurements (Cmax). Mean graphical presentation of the data will be reported.
Statistical analysis of exposure parameters will be performed.
Measured: 10 days
Time concentration data measurements by subject and by group (Tmax)
Comparison will be performed between the groups for time concentration data measurements (Tmax)
Measured: 10 days
Area under the plasma concentration versus time curve (AUC) between groups
Comparison will be performed between the groups for area under the plasma concentration versus time curve (AUC) Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.
Measured: 10 days
Urine Pharmacokinetic (PK) amount excreted by subject and by group
Urine Pharmacokinetic (PK) parameters such as amount excreted will be calculated from urinary excretion data
Measured: 10 days
Urine Pharmacokinetic (PK) % dose excreted by subject and by group
Urine Pharmacokinetic (PK) parameters such as amount of % dose excreted will be calculated from urinary excretion data
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start10 Nov 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Open-label, single dose design
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qpex Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc., Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Jeff Loutit, MBChB, Study director, Qpex Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157242
- Sponsor's protocol ID
- Qpex-103
- Status last verified
- May 2025
- First submitted
- 27 Nov 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06157242
- Acronym / sponsor ID
- Qpex-103
- Conditions
- Bacterial Infections
- Keywords
- beta-lactamase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Qpex Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc., Biomedical Advanced Research and Development Authority
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the PK of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment.
- To evaluate the safety and tolerability of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single dose design
| Arm | Type | Receives |
|---|---|---|
| Open Label, Single Dose Combination of Ceftibuten & Xeruborbactam oral prodrug | Experimental | Drug: Xeruborbactam Oral Prodrug, Drug: Ceftibuten24 pts will be enrolled with varying degrees of RI as well as 8 participants with normal renal function (NRF). 8 participants will be enrolled in each group (G) based on estimated glomerular function rate (eGFR) at screening: * G1: Mild RI (eGFR 60 to 90 mL/min/1.73m2 calculated using the 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/1.73m2 calculated using the CKD-EPI equation adjusted for the participant's BSA) * G3: Severe RI (eGFR < 30 mL/min/1.73m2 calculated using the CKD-EPI equation) not receiving dialysis therapy * G4: Healthy participants with NRF matched to patients in Groups 1, 2 and 3 based on age, gender and BMI All pts will receive a single dose of ceftibuten \& QPX7831 on Day 1. Pts will remain in the clinic until completion of the post-dose procedures on Day 8. Participants will be contacted by phone between Days 10-12 for follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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.
- Males and females at least 18 years of age, at the time of consent.
- 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.
- 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:
- 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:
Key exclusion criteria (28 listed)
- 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.
- 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.
- History of clinically significant seizures, head injury, or meningitis.
- 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.
- Females who are pregnant, lactating, or have a positive pregnancy test at the screening visit or day -1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xeruborbactam Oral ProdrugAlso: QPX7831Experimental | Drug | Open Label, Single Dose Combination of Ceftibuten & Xeruborbactam oral prodrug |
| CeftibutenExperimental | Drug | Open Label, Single Dose Combination of Ceftibuten & Xeruborbactam oral prodrug |
Primary outcome
Incidence of Treatment Emergent adverse events by subject and by group
Time frame: 10 days
Number of patients with Treatment-Emergent Adverse Events by subject, by group, severity and relationship to treatment
Number of patients with changes from baseline in safety parameters
Time frame: 10 days
Number of patients with changes in safety parameters before and after dosing by subject and group
Peak plasma Concentration measurements by subject and by group (Cmax)
Time frame: 10 days
Comparison will be performed between the groups for concentration measurements (Cmax). Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.
Time concentration data measurements by subject and by group (Tmax)
Time frame: 10 days
Comparison will be performed between the groups for time concentration data measurements (Tmax)
Area under the plasma concentration versus time curve (AUC) between groups
Time frame: 10 days
Comparison will be performed between the groups for area under the plasma concentration versus time curve (AUC) Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.
Urine Pharmacokinetic (PK) amount excreted by subject and by group
Time frame: 10 days
Urine Pharmacokinetic (PK) parameters such as amount excreted will be calculated from urinary excretion data
Urine Pharmacokinetic (PK) % dose excreted by subject and by group
Time frame: 10 days
Urine Pharmacokinetic (PK) parameters such as amount of % dose excreted will be calculated from urinary excretion data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Loutit, MBChB study director
Qpex Biopharma, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xeruborbactam Oral Prodrug and Ceftibuten in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent adverse events by subject and by group (time frame: 10 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.