Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants

NCT07083817 | Completed Phase 1

• 1 other identifier: Qpex-403
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (21)

• Amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Fe)

  Day 1 to Day 15

• Cumulative amount of total radioactivity excreted expressed as percentage of the radioactive dose administered (CumFe)

  Day 1 to Day 15

• Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on Cmax

  Day 1 to Day 15

• Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-last

  Day 1 to Day 15

• Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-inf

  Day 1 to Day 15

• Whole blood to plasma total radioactivity ratio based on Cmax

  Day 1 to Day 15

• Whole blood to plasma total radioactivity ratio based on AUC0-last

  Day 1 to Day 15

• Whole blood to plasma total radioactivity ratio based on AUC0-inf

  Day 1 to Day 15

• Maximum plasma concentration (Cmax) for xeruborbactam

  Day 1 to Day 15

• Time to maximum plasma concentration (Tmax) for xeruborbactam

  Day 1 to Day 15

• Area under the concentration time curve from zero to infinity (AUC0-inf) for xeruborbactam

  Day 1 to Day 15

• Maximum plasma and whole blood concentration (Cmax) of total radioactivity

  Day 1 to Day 15

• Time to maximum plasma and whole blood concentration (Tmax) of total radioactivity

  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

  Day 1 to Day 15

• Amount of total radioactivity excreted in urine (Aeu)

  Day 1 to Day 15

• Amount of total radioactivity excreted in in urine expressed as a percentage of the radioactive dose administered (Feu)

  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)

  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

  Day 1 to Day 15

• Total amount of radioactivity excreted (Ae)

  Day 1 to Day 15

• Cumulative amount of total radioactivity excreted (CumAe)

  Day 1 to Day 15

• Ratio of whole blood to plasma total radioactivity

  Day 1 to Day 15

Secondary Outcomes (1)

• Percentage of participants with Treatment-Emergent Adverse Events

  Day 1 to Day 15

Study Arms (1)

[14C]Xeruborbactam

EXPERIMENTAL

Drug: [14C]Xeruborbactam

Interventions

[14C]Xeruborbactam DRUG

Carbon Radiolabeled Xeruborbactam

[14C]Xeruborbactam

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qpex Biopharma, Inc.: lead
• Shionogi Inc.: collaborator

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 24, 2025
• Study Start: August 13, 2025
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

GB (1)