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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on Cmax
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
[14C]Xeruborbactam
干预措施: [14C]Xeruborbactam (Drug)
结局指标
主要结局
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on Cmax
时间窗: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-inf
时间窗: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on AUC0-last
时间窗: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on AUC0-inf
时间窗: Day 1 to Day 15
Time to maximum plasma and whole blood concentration (Tmax) of total radioactivity
时间窗: Day 1 to Day 15
Amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Fe)
时间窗: Day 1 to Day 15
Cumulative amount of total radioactivity excreted expressed as percentage of the radioactive dose administered (CumFe)
时间窗: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-last
时间窗: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on Cmax
时间窗: 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
时间窗: Day 1 to Day 15
Maximum plasma concentration (Cmax) for xeruborbactam
时间窗: Day 1 to Day 15
Amount of total radioactivity excreted in urine (Aeu)
时间窗: Day 1 to Day 15
Time to maximum plasma concentration (Tmax) for xeruborbactam
时间窗: Day 1 to Day 15
Area under the concentration time curve from zero to infinity (AUC0-inf) for xeruborbactam
时间窗: Day 1 to Day 15
Maximum plasma and whole blood concentration (Cmax) of total radioactivity
时间窗: Day 1 to Day 15
Amount of total radioactivity excreted in in urine expressed as a percentage of the radioactive dose administered (Feu)
时间窗: 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)
时间窗: 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
时间窗: Day 1 to Day 15
Total amount of radioactivity excreted (Ae)
时间窗: Day 1 to Day 15
Cumulative amount of total radioactivity excreted (CumAe)
时间窗: Day 1 to Day 15
Ratio of whole blood to plasma total radioactivity
时间窗: Day 1 to Day 15
次要结局
- Percentage of participants with Treatment-Emergent Adverse Events(Day 1 to Day 15)