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

NCT ID: NCT07083817

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-13
• Study Completion Date: 2025-08-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[14C]Xeruborbactam

Group Type: EXPERIMENTAL

[14C]Xeruborbactam

Intervention Type: DRUG

Carbon Radiolabeled Xeruborbactam

Interventions

[14C]Xeruborbactam

Carbon Radiolabeled Xeruborbactam

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shionogi Inc.

INDUSTRY

Sponsor Role: collaborator

Qpex Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quotient Sciences

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

Qpex-403

Identifier Type: -

Identifier Source: org_study_id