Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants
Not Applicable
Active, not recruiting
- Conditions
- ADME
- Interventions
- Drug: [14C]Xeruborbactam
- Registration Number
- NCT07083817
- Lead Sponsor
- Qpex Biopharma, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]Xeruborbactam [14C]Xeruborbactam -
- Primary Outcome Measures
Name Time Method 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-inf 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 Time to maximum plasma and whole blood concentration (Tmax) of total radioactivity Day 1 to Day 15 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 AUC0-last Day 1 to Day 15 Whole blood to plasma total radioactivity ratio based on Cmax 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 Maximum plasma concentration (Cmax) for xeruborbactam Day 1 to Day 15 Amount of total radioactivity excreted in urine (Aeu) 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 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 Outcome Measures
Name Time Method Percentage of participants with Treatment-Emergent Adverse Events Day 1 to Day 15
Trial Locations
- Locations (2)
Quotient Sciences
🇬🇧Nottingham, United Kingdom
Quotient Sciences
🇬🇧Nottingham, United Kingdom
Quotient Sciences🇬🇧Nottingham, United Kingdom