Bacterial InfectionsPhase 1NCT06079775
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
A Phase 1 study testing Xeruborbactam Oral Prodrug and Ceftibuten in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in Australia.
Trial summary
A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination with Ceftibuten in Healthy Adult Participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy 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?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Jan 2024to 5 Jan 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be eligible to be included in the study only if all of the following criteria apply:
- Age
- Participant must be a healthy adult male or female, 18 to 55 years of age (inclusive) at the time of screening.
- Type of Participant and Disease Characteristics
- Participants who are overtly medically healthy with clinically insignificant screening results (eg, laboratory profiles, medical histories, ECGs, physical examination) as assessed by the investigator, sub-investigator, or medical officer.
- Weight
Show all 19Show fewer
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). Note: BMI = kg/m2 where kg is a weight in kilograms and m2 is a height in meters squared.
- Sex and Contraceptive/Barrier Requirements
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants:
- If male, agree to be sexually abstinent or agree to use 2 approved methods of contraception (refer to inclusion criterion #5) when engaging in sexual activity from study check-in through 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary.
- Female participants:
- Females of childbearing potential must either be sexually abstinent for 14 days prior to Day 1 and agree to remain so through 30 days following the last administration of the study drug, OR have been using (or agree to use) 2 of the following acceptable methods of birth control for the times specified:
- Intra-uterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days following the final dosing of the study drug
- Barrier method (condom or diaphragm) for at least 14 days prior to Day 1 through 30 days following the final dosing of the study drug
- Stable hormonal contraceptive for at least 3 months prior to Day 1 and barrier method (condom or diaphragm) for at least 14 days prior to Day 1 through 30 days following final dosing of the study drug
- Surgical sterilization (vasectomy) of partner at least 6 months prior to Day 1
- Informed Consent
- Capable of giving signed informed consent as described in Appendix 1 Informed Consent Form (Section 10.1.3) that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Participants will be excluded from the study if any of the following criteria apply:
- Medical Conditions
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Documented hypersensitivity reaction or anaphylaxis to any medication, including ceftibuten or other beta-lactam antibiotics (e.g. cephalosporins, penicillins, carbapenems or monobactams) or any excipients used in this formulation.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Females who are pregnant or lactating.
Show all 29Show fewer
- Surgery within the past 3 months prior to Day 1 determined by the investigator, sub-investigator, or medical officer to be clinically relevant.
- Any acute illness within 30 days prior to Day 1.
- Any other condition or prior therapy, which, in the opinion of the investigator, sub-investigator, or medical officer would make the participant unsuitable for this study.
- Prior/Concomitant Therapy
- Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to Day 1.
- Use of any over-the-counter medication, including herbal products, probiotics and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of paracetamol is allowed for acute events at the discretion of the investigator, sub-investigator, or medical officer.
- Use of antacids, H2 receptor blockers or proton pump inhibitors 7 days prior to Day 1. This includes calcium carbonate.
- Prior/Concurrent Clinical Study Experience
- Participation in another investigational clinical trial within 30 days prior to Day 1 or within 5 half-lives of the previous investigational drug, whichever is longer.
- Diagnostic Assessments
- QTc corrected according to Fridericia's formula (QTcF) interval > 450 msec for males and > 470 for females or history of prolonged QT syndrome at screening or check-in (Day -1).
- Calculated creatinine clearance < 80 mL/min (Cockcroft-Gault method) at screening or check-in (Day -1).
- Any clinically significant abnormalities in laboratory values at screening or check-in (Day -1), in particular:
- White blood cell count < 3,000/mm3, hemoglobin < 11g/dL
- Absolute neutrophil count < 1,200/mm3 or platelet count < 120,000/mm3
- Liver function abnormalities at screening or check-in (Day -1) (defined by an elevation in bilirubin, AST, or ALT > ULN for participants based on age and sex)
- Other Exclusion Criteria
- Blood donation or significant blood loss (ie, > 500 mL) within 56 days prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Positive urine drug/alcohol testing at screening or check-in (Day -1).
- History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
- Use of more than 5 packs/week of cigarettes (or equivalent amount of nicotine-containing product) within 6 months prior to Day 1. Use of all nicotine containing products 48 hours prior to admission to clinical research unit. Participants must agree to refrain from smoking for the duration of the study.
- Excessive intake of alcohol, defined as an average daily intake of > 2 standard drinks for women and > 4 standard drinks for men, (standard drink is the equivalent to 4 oz of wine (approximately 12% abv), 12 oz of regular beer (approximately 5% abv), or 1.5 oz of spirits (80 proof).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination With Ceftibuten in Healthy Adult Participants
A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination with Ceftibuten in Healthy Adult Participants
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 Phase 1 study will assess if a PK interaction exists between xeruborbactam oral prodrug and ceftibuten when given in combination at doses of each drug that have previously been shown to be safe. The study will also assess the safety of the combination with dosing over 10 days.
Study Objectives:
- To assess the safety, tolerability, and PK of single and multiple doses of xeruborbactam oral prodrug and ceftibuten both in combination and alone, in healthy adult participants.
- To assess whether there is any PK interaction between xeruborbactam oral prodrug and ceftibuten when administered in combination to healthy adult participants.
- Conditions
- Bacterial Infections
- Being tested
- Xeruborbactam Oral Prodrug, Ceftibuten, Xeruborbactam Oral Prodrug Placebo, Ceftibuten Placebo
- 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
Xeruborbactam Oral Prodrug PlaceboDrug
Also called QPX7831 Placebo
Placebo Comparator
Ceftibuten PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Drug-Drug-Interaction Crossover & Multiple Dose Cohorts | Experimental | DDI crossover part of the study, subjects will be enrolled into 3 cohorts of 8 subjects each, Cohorts 1, 2, \& 3 respectively.
All subjects in Cohorts 1, 2, and 3 will receive a single dose of xeruborbactam oral prodrug (XOP) on Day 1. On Day 6, they will receive a single dose of ceftibuten. On Day 9 they will receive a single combined dose of XOP and ceftibuten.
During the MAD part of the study, subjects will be enrolled into 2 cohorts, Cohorts 4 \& 5 respectively.
Subjects in Cohorts 4 (16 subjects) will receive either a combined dose of XOP and ceftibuten, active ceftibuten, or active XOP.
Cohort 4 will be dosed BID on Days 1-9, with last dose on the morning of Day 10.
Subjects in Cohort 5 (15 subjects) will receive active XOP in comb with active ceftibuten which will be admin orally either twice on Day 1 and QD on Days 2-10 (Group 1), BID on Days 1-9 and QD on Day 10 (Group 2), or TID on Days 1-9 and once on Day 10 (Group 3), based on group assignment. Receives: Drug: Xeruborbactam Oral Prodrug; Drug: Ceftibuten |
| Placebo Comparator to maintain the blind | Placebo comparator | During Cohort 4, Xeruborbactam Oral Prodrug Placebo and Ceftibuten placebo will be used to maintain the blind. In Cohort 4, ten (10) subjects in each cohort will receive a combined dose of xeruborbactam oral prodrug and ceftibuten. Three (3) subjects in each cohort will receive active ceftibuten capsules with xeruborbactam oral prodrug placebo capsules. Three (3) subjects in each cohort will receive active xeruborbactam oral prodrug capsules with ceftibuten placebo capsules. Receives: Drug: Xeruborbactam Oral Prodrug Placebo; Drug: Ceftibuten Placebo |
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 cohort (single dose, multiple doses)
Number of patients with Treatment-Emergent Adverse Events by subject, by cohort, severity and relationship to treatment
Measured: 16 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 cohort
Measured: 16 days
Peak plasma Concentration measurements by subject and by cohort (Cmax)
Comparison will be performed between the cohorts for concentration measurements (Cmax). Mean graphical presentation of the data will be reported.
Statistical analysis of exposure parameters will be performed.
Measured: 16 days
Time concentration data measurements by subject and by cohort (Tmax)
Comparison will be performed between the cohorts for time concentration data measurements (Tmax)
Measured: 16 days
Area under the plasma concentration versus time curve (AUC) between cohorts
Comparison will be performed between the cohorts 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: 16 days
Urine Pharmacokinetic (PK) amount excreted by subject and by cohort
Urine Pharmacokinetic (PK) parameters such as amount excreted will be calculated from urinary excretion data
Measured: 16 days
Urine Pharmacokinetic (PK) % dose excreted by subject and by cohort
Urine Pharmacokinetic (PK) parameters such as amount of % dose excreted will be calculated from urinary excretion data
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start30 Jan 2024
- Primary completion5 Jan 2025
- Study completion5 Jan 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
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, Double-Blind, Controlled, Crossover, ascending single-and multipledose design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 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
- NCT06079775
- Sponsor's protocol ID
- Qpex-102
- Status last verified
- Jun 2025
- First submitted
- 6 Oct 2023
- Last updated
- 12 Dec 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination With Ceftibuten in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06079775
- Acronym / sponsor ID
- Qpex-102
- Conditions
- Bacterial Infections
- Keywords
- beta-lactamase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Qpex Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc., Biomedical Advanced Research and Development Authority
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 12 Oct 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, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination with Ceftibuten in Healthy Adult Participants
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 Phase 1 study will assess if a PK interaction exists between xeruborbactam oral prodrug and ceftibuten when given in combination at doses of each drug that have previously been shown to be safe. The study will also assess the safety of the combination with dosing over 10 days.
Study Objectives:
- To assess the safety, tolerability, and PK of single and multiple doses of xeruborbactam oral prodrug and ceftibuten both in combination and alone, in healthy adult participants.
- To assess whether there is any PK interaction between xeruborbactam oral prodrug and ceftibuten when administered in combination to healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Controlled, Crossover, ascending single-and multipledose design
| Arm | Type | Receives |
|---|---|---|
| Single Dose Drug-Drug-Interaction Crossover & Multiple Dose Cohorts | Experimental | Drug: Xeruborbactam Oral Prodrug, Drug: CeftibutenDDI crossover part of the study, subjects will be enrolled into 3 cohorts of 8 subjects each, Cohorts 1, 2, \& 3 respectively. All subjects in Cohorts 1, 2, and 3 will receive a single dose of xeruborbactam oral prodrug (XOP) on Day 1. On Day 6, they will receive a single dose of ceftibuten. On Day 9 they will receive a single combined dose of XOP and ceftibuten. During the MAD part of the study, subjects will be enrolled into 2 cohorts, Cohorts 4 \& 5 respectively. Subjects in Cohorts 4 (16 subjects) will receive either a combined dose of XOP and ceftibuten, active ceftibuten, or active XOP. Cohort 4 will be dosed BID on Days 1-9, with last dose on the morning of Day 10. Subjects in Cohort 5 (15 subjects) will receive active XOP in comb with active ceftibuten which will be admin orally either twice on Day 1 and QD on Days 2-10 (Group 1), BID on Days 1-9 and QD on Day 10 (Group 2), or TID on Days 1-9 and once on Day 10 (Group 3), based on group assignment. |
| Placebo Comparator to maintain the blind | Placebo comparator | Drug: Xeruborbactam Oral Prodrug Placebo, Drug: Ceftibuten PlaceboDuring Cohort 4, Xeruborbactam Oral Prodrug Placebo and Ceftibuten placebo will be used to maintain the blind. In Cohort 4, ten (10) subjects in each cohort will receive a combined dose of xeruborbactam oral prodrug and ceftibuten. Three (3) subjects in each cohort will receive active ceftibuten capsules with xeruborbactam oral prodrug placebo capsules. Three (3) subjects in each cohort will receive active xeruborbactam oral prodrug capsules with ceftibuten placebo capsules. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Participants will be eligible to be included in the study only if all of the following criteria apply:
- Age
- Participant must be a healthy adult male or female, 18 to 55 years of age (inclusive) at the time of screening.
- Type of Participant and Disease Characteristics
- Participants who are overtly medically healthy with clinically insignificant screening results (eg, laboratory profiles, medical histories, ECGs, physical examination) as assessed by the investigator, sub-investigator, or medical officer.
Key exclusion criteria (29 listed)
- Medical Conditions
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Documented hypersensitivity reaction or anaphylaxis to any medication, including ceftibuten or other beta-lactam antibiotics (e.g. cephalosporins, penicillins, carbapenems or monobactams) or any excipients used in this formulation.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Females who are pregnant or lactating.
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 | Single Dose Drug-Drug-Interaction Crossover & Multiple Dose Cohorts |
| CeftibutenExperimental | Drug | Single Dose Drug-Drug-Interaction Crossover & Multiple Dose Cohorts |
| Xeruborbactam Oral Prodrug PlaceboAlso: QPX7831 PlaceboPlacebo Comparator | Drug | Placebo Comparator to maintain the blind |
| Ceftibuten PlaceboPlacebo Comparator | Drug | Placebo Comparator to maintain the blind |
Primary outcome
Incidence of Treatment -Emergent Adverse events by subject and by cohort (single dose, multiple doses)
Time frame: 16 days
Number of patients with Treatment-Emergent Adverse Events by subject, by cohort, severity and relationship to treatment
Number of patients with changes from baseline in safety parameters
Time frame: 16 days
Number of patients with changes in safety parameters before and after dosing by subject and cohort
Peak plasma Concentration measurements by subject and by cohort (Cmax)
Time frame: 16 days
Comparison will be performed between the cohorts 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 cohort (Tmax)
Time frame: 16 days
Comparison will be performed between the cohorts for time concentration data measurements (Tmax)
Area under the plasma concentration versus time curve (AUC) between cohorts
Time frame: 16 days
Comparison will be performed between the cohorts 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 cohort
Time frame: 16 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 cohort
Time frame: 16 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 12 Dec 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.
1 site 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 1 site in Australia.
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 19 inclusion and 29 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. Some participants in this study may receive a placebo. 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 cohort (single dose, multiple doses) (time frame: 16 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 12 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.