An Open Label, Single-Dose Study to Assess the Mass Balance Recovery, Metabolism and Excretion of [14C] ANG 3777 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Measurement of the appropriate PK parameters of TR in urine including but not limited to: Cmax
研究概览
简要总结
The purpose of this study is to assess the mass balance recovery and metabolic profiling and identification of 14C-ANG-3777 administered as a single IV dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Healthy males
- •Aged 30 to 65 years inclusive at the time of signing informed consent
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2 and weighing 50 to 120 kg as measured at screening
- •Must be willing and able to communicate and participate in the whole study
- •Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
- •Must provide written informed consent
- •Must agree to adhere to the contraception requirements
排除标准
- •Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- •Subjects who are, or are immediate family members of, a study site or sponsor employee
- •Evidence of current SARS-CoV-2 infection.
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- •A confirmed positive alcohol breath test at screening or admission
- •Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
研究组 & 干预措施
carbon-14-[14C]-ANG-3777
Administered IV as a single dose over 30 minutes on the morning of Day 1 following an 8 hour overnight fast and remain in the clinical unit until up to 168 hours after dosing (to Day 8). If mass balance criteria have not been met on Day 8, the clinical unit residency may be extended up to an additional 96 hours (to Day 12).
干预措施: carbon-14-[14C]-ANG-3777 (Drug)
结局指标
主要结局
Measurement of the appropriate PK parameters of TR in urine including but not limited to: Cmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Tmax
时间窗: Day 1 to Day 8
Mass balance recovery of total radioactivity (TR) in all excreta faeces: CumAe and Cum%Ae
时间窗: Day 1 to Day 8 (or Day 1 to Day 12)
Collection of plasma samples for metabolite profiling, structural identification, and quantification analysis
时间窗: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
Collection of urine samples for metabolite profiling, structural identification, and quantification analysis
时间窗: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
Collection of faeces samples for metabolite profiling, structural identification, and quantification analysis
时间窗: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
Determination of routes of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval
时间窗: Day 1 to Day 12
Determination of rates of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval
时间窗: Day 1 to Day 12
Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Tmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Cmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: AUC(0-last), and AUC(0-inf)
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in plasma including but not limited to: AUC(0-last), and AUC(0-inf)
时间窗: Day 1 to Day 8
Mass balance recovery of total radioactivity (TR) in all excreta urine: CumAe and Cum%Ae
时间窗: Day 1 to Day 8 (or Day 1 to Day 12)
Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Tmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in urine including but not limited to: AUC(0-last), and AUC(0-inf)
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: AUC(0-last) and AUC(0-inf)
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Tmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Cmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: AUC(0-last), and AUC(0-inf)
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Cmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Tmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Cmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in urine including but not limited to: Tmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Cmax
时间窗: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in faeces including but not limited to: AUC(0-last), and AUC(0-inf)
时间窗: Day 1 to Day 8
Evaluation of whole blood:plasma concentration ratios for TR
时间窗: Plasma from Day 1 to Day 8; whole blood up to Day 2
次要结局
未报告次要终点