ADMEPhase 1NCT07083817
Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants
A Phase 1 study testing [14C]Xeruborbactam in people with ADME, run by Qpex Biopharma, Inc. at 1 site in United Kingdom.
Trial summary
This is a single-dose, phase 1 open-label study to determine the mass balance recovery and metabolic profiling and identification for intravenous (IV) administered [14C]xeruborbactam. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- ADME
- What is being tested?
- [14C]Xeruborbactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2025to 27 Aug 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and cardiac (12-lead electrocardiogram (ECG)) monitoring.
- Body weight within 55.0 and 100.0 kg (inclusive) and body mass index (BMI) within the range of 18.0 and 32.0 kg/m2 (inclusive).
- Participants who have regular bowel movements (ie, average stool production of ≥ 1 and ≤ 3 stools per day)
- Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent
Who cannot join
- History or presence of significant cardiovascular, respiratory/pulmonary, hepatic, renal, hematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurological, or psychiatric disease capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data
- Surgery within the past 3 months prior to Day 1 determined by the investigator to be clinically relevant
- History of GI surgery including but not limited to, gastric resection and/or intestinal resection that may result in a clinically significant abnormality in GI function (expect for an appendectomy for noncomplicated appendicitis unless it was performed in the previous 12 months)
- Acute diarrhea, loose stools, or constipation within 14 days prior to the screening visit or upon admission to the clinical research unit (CRU) (Day -1). Diarrhea will be defined as the passage of liquid faeces and/or a stool frequency of ≥ 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Phase 1, Open-label Study to Evaluate the Mass Balance and Absorption, Distribution, Metabolism, and Excretion of [14C]Xeruborbactam (QPX7728) Following Administration of a Solution for Intravenous Infusion in Healthy Adult Male Participants
This is a single-dose, phase 1 open-label study to determine the mass balance recovery and metabolic profiling and identification for intravenous (IV) administered [14C]xeruborbactam. This study will investigate the primary route of excretion, profile [14C]xeruborbactam metabolites in plasma, urine and faeces, and assess the safety, tolerability, and pharmacokinetics (PK) of a single IV dose of [14C]xeruborbactam in healthy adult male participants.
- Conditions
- ADME
- Being tested
- [14C]Xeruborbactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]XeruborbactamDrug
Carbon Radiolabeled Xeruborbactam
| Study group | Role | What they receive |
|---|---|---|
| [14C]Xeruborbactam | Experimental | Not described Receives: Drug: [14C]Xeruborbactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Fe)
Measured: Day 1 to Day 15
Cumulative amount of total radioactivity excreted expressed as percentage of the radioactive dose administered (CumFe)
Measured: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on Cmax
Measured: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-last
Measured: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-inf
Measured: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on Cmax
Measured: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on AUC0-last
Measured: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on AUC0-inf
Measured: Day 1 to Day 15
Maximum plasma concentration (Cmax) for xeruborbactam
Measured: Day 1 to Day 15
Time to maximum plasma concentration (Tmax) for xeruborbactam
Measured: Day 1 to Day 15
Area under the concentration time curve from zero to infinity (AUC0-inf) for xeruborbactam
Measured: Day 1 to Day 15
Maximum plasma and whole blood concentration (Cmax) of total radioactivity
Measured: Day 1 to Day 15
Time to maximum plasma and whole blood concentration (Tmax) of total radioactivity
Measured: Day 1 to Day 15
Area under the concentration time curve from zero to infinity (AUC0-inf) of total radioactivity in plasma and whole blood
Measured: Day 1 to Day 15
Amount of total radioactivity excreted in urine (Aeu)
Measured: Day 1 to Day 15
Amount of total radioactivity excreted in in urine expressed as a percentage of the radioactive dose administered (Feu)
Measured: Day 1 to Day 15
Identification of the chemical structure of each metabolite accounting for 5% or more in plasma by area under the time concentration curve (AUC)
Measured: Day 1 to Day 15
Identification of the chemical structure of each metabolite in urine and faeces that account for 5% or more of the administered radioactive dose
Measured: Day 1 to Day 15
Total amount of radioactivity excreted (Ae)
Measured: Day 1 to Day 15
Cumulative amount of total radioactivity excreted (CumAe)
Measured: Day 1 to Day 15
Ratio of whole blood to plasma total radioactivity
Measured: Day 1 to Day 15
Secondary outcomes (1)
Percentage of participants with Treatment-Emergent Adverse Events
Measured: Day 1 to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start13 Aug 2025
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADMEStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qpex Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083817
- Sponsor's protocol ID
- Qpex-403
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Phase 1, Open-label Study to Evaluate the Mass Balance and Absorption, Distribution, Metabolism, and Excretion of [14C]Xeruborbactam (QPX7728) Following Administration of a Solution for Intravenous Infusion in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT07083817
- Acronym / sponsor ID
- Qpex-403
- Conditions
- ADME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Qpex Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc.
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 24 Jul 2025 (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.
This is a single-dose, phase 1 open-label study to determine the mass balance recovery and metabolic profiling and identification for intravenous (IV) administered [14C]xeruborbactam. This study will investigate the primary route of excretion, profile [14C]xeruborbactam metabolites in plasma, urine and faeces, and assess the safety, tolerability, and pharmacokinetics (PK) of a single IV dose of [14C]xeruborbactam in healthy adult male participants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]Xeruborbactam | Experimental | Drug: [14C]Xeruborbactam |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and cardiac (12-lead electrocardiogram (ECG)) monitoring.
- Body weight within 55.0 and 100.0 kg (inclusive) and body mass index (BMI) within the range of 18.0 and 32.0 kg/m2 (inclusive).
- Participants who have regular bowel movements (ie, average stool production of ≥ 1 and ≤ 3 stools per day)
- Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent
Key exclusion criteria (5 listed)
- History or presence of significant cardiovascular, respiratory/pulmonary, hepatic, renal, hematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurological, or psychiatric disease capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data
- Surgery within the past 3 months prior to Day 1 determined by the investigator to be clinically relevant
- History of GI surgery including but not limited to, gastric resection and/or intestinal resection that may result in a clinically significant abnormality in GI function (expect for an appendectomy for noncomplicated appendicitis unless it was performed in the previous 12 months)
- Acute diarrhea, loose stools, or constipation within 14 days prior to the screening visit or upon admission to the clinical research unit (CRU) (Day -1). Diarrhea will be defined as the passage of liquid faeces and/or a stool frequency of ≥ 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
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 |
|---|---|---|
| [14C]XeruborbactamCarbon Radiolabeled Xeruborbactam | Drug | [14C]Xeruborbactam |
Primary outcome
Amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Fe)
Time frame: Day 1 to Day 15
Cumulative amount of total radioactivity excreted expressed as percentage of the radioactive dose administered (CumFe)
Time frame: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on Cmax
Time frame: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-last
Time frame: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-inf
Time frame: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on Cmax
Time frame: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on AUC0-last
Time frame: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on AUC0-inf
Time frame: Day 1 to Day 15
Maximum plasma concentration (Cmax) for xeruborbactam
Time frame: Day 1 to Day 15
Time to maximum plasma concentration (Tmax) for xeruborbactam
Time frame: Day 1 to Day 15
Area under the concentration time curve from zero to infinity (AUC0-inf) for xeruborbactam
Time frame: Day 1 to Day 15
Maximum plasma and whole blood concentration (Cmax) of total radioactivity
Time frame: Day 1 to Day 15
Time to maximum plasma and whole blood concentration (Tmax) of total radioactivity
Time frame: Day 1 to Day 15
Area under the concentration time curve from zero to infinity (AUC0-inf) of total radioactivity in plasma and whole blood
Time frame: Day 1 to Day 15
Amount of total radioactivity excreted in urine (Aeu)
Time frame: Day 1 to Day 15
Amount of total radioactivity excreted in in urine expressed as a percentage of the radioactive dose administered (Feu)
Time frame: Day 1 to Day 15
Identification of the chemical structure of each metabolite accounting for 5% or more in plasma by area under the time concentration curve (AUC)
Time frame: Day 1 to Day 15
Identification of the chemical structure of each metabolite in urine and faeces that account for 5% or more of the administered radioactive dose
Time frame: Day 1 to Day 15
Total amount of radioactivity excreted (Ae)
Time frame: Day 1 to Day 15
Cumulative amount of total radioactivity excreted (CumAe)
Time frame: Day 1 to Day 15
Ratio of whole blood to plasma total radioactivity
Time frame: Day 1 to Day 15
1 secondary outcome
Percentage of participants with Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 15
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 29 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 [14C]Xeruborbactam in people with ADME, run by Qpex Biopharma, Inc. at 1 site in United Kingdom.
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 5 inclusion and 5 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 29 Aug 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 United Kingdom. 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?
Amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Fe) (time frame: Day 1 to Day 15). The study lists 21 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 29 Aug 2025.