A Phase I, Open-label Study of the Metabolism and Excretion of [14C]-Zidebactam (WCK 5107) Following a Single Intravenous Infusion in Healthy Male Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage excreted in urine (feu):
研究概览
简要总结
A Phase 1, Open-label Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion in Healthy Male Subjects
详细描述
The primary objectives of the study are:
- To determine mass balance and routes of elimination of [zidebactam following administration of a single 1g (approximately 200 μCi) radiolabeled intravenous (IV) infusion of zidebactam in healthy male subjects
- To assess the pharmacokinetics (PK) of a single IV infusion of zidebactam
- To determine the whole blood and plasma concentrations of total radioactivity following a single IV infusion of -zidebactam
- To determine the urinary and fecal recovery of the total administered radioactive dose
The secondary objectives of the study are:
- To characterize and identify metabolites of zidebactam in plasma, urine, and feces, as applicable
- To determine plasma and urine concentrations of non-radiolabeled zidebactam
- To assess the safety and tolerability of zidebactam
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.5 and 29.9 kg/m2, inclusive at Screening and Check-in (Day -1).
- •In good health, determined by no clinically significant findings from medical history, physical examination (at Check-in [Day -1]), 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
- •Blood pressure between 90 and 140 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic, unless deemed not clinically significant by the Investigator (or designee).
- •History of a minimum of 1 bowel movement per day.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- •History of alcoholism or drug/chemical abuse within 1 year prior to Check-in (Day -1).
- •Alcohol consumption of >28 units per week for males. One unit of alcohol equals 12 oz. (360 mL) of beer, 1½ oz. (45 mL) of liquor, or 5 oz. (150 mL) of wine.
- •Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 14 days prior to Check-in.
- •Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
研究组 & 干预措施
zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour
干预措施: zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour (Drug)
结局指标
主要结局
Percentage excreted in urine (feu):
时间窗: 7 days
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the percentage excreted in urine (feu).
Amount Excreted in Urine (Aeu)
时间窗: 7 days
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the amount excreted in urine (Aeu).
Cumulative Aeu in urine (Cum Aeu)
时间窗: 7 days
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the cumulative Aeu (Cum Aeu).
Cumulative feu in urine(Cum feu):
时间窗: 7 days
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the cumulative feu (Cum feu).
Renal clearance (zidebactam only; CLR):
时间窗: 7 days
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the renal clearance (zidebactam only; CLR).
Amount excreted in feces (Aef):
时间窗: 7 days
The primary PK outcome endpoints of total radioactivity derived from fecal collections were the amount excreted in feces (Aef).
Cumulative Aef in feces (Cum Aef):
时间窗: 7 days
The primary PK outcome endpoints of total radioactivity derived from fecal collections were the cumulative Aef (Cum Aef).
Percentage excreted in feces (fef):
时间窗: 7 days
The primary PK outcome endpoints of total radioactivity derived from fecal collections were the percentage excreted in feces (fef).
Cumulative fef in feces (Cum fef):
时间窗: 7 days
The primary PK outcome endpoints of total radioactivity derived from fecal collections were the cumulative fef (Cum fef).
次要结局
- Physical Examinations(7 days)
- Vital Signs- supine pulse rate(7 days)
- Vital Signs- respiratory rate(7 Days)
- Vital signs- oral body temperature(7 days)
- Identification of [14C]-zidebactam metabolites(7 days)
- Incidence and severity of AEs(7 Days)
- Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results(7 days)
- 12-lead electrocardiogram (ECG) parameters(7 days)
- Vital Signs -Supine Blood Pressure(7 days)
- Metabolic Profile of [14C]-zidebactam(7 days)