An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Uproleselan Administered Via the Intravenous Route to Healthy Subjects (ADME Study of IV [14C]-Uproleselan in Healthy Subjects)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mass Balance Recovery
研究概览
简要总结
The purpose of the study is to measure how the radiolabelled test medicine [14C]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the drug is in the body. Blood urine and fecal samples will be collected at specific times throughout the study to measure amounts of the test medicine in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Age 30 to 65 years of age
- •Body mass index (BMI) of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- •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 adhere to the contraception requirements
排除标准
- •Subjects who have received any IMP in a clinical research study within the previous 3 months
- •Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption
- •Current smoking or use of tobacco products or substitutes.
- •Current users of e-cigarettes and nicotine replacements products
- •Radiation exposure
- •Subjects who have completed 2 ADME studies in the last 12 months
- •Clinically significant abnormal biochemistry, hematology or urinalysis
- •Positive drugs of abuse test result
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •Evidence of renal impairment at screening
- •History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •Presence or history of clinically significant allergy requiring treatment
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Subjects who are taking, or have taken, any prescribed or over-the-counter drug
- •Vaccination with any live vaccine within 4 weeks of study drug administration
研究组 & 干预措施
Single IV administration of [14C]-Uproleselan
干预措施: Uproleselan (Drug)
结局指标
主要结局
Mass Balance Recovery
时间窗: up to 8 days
Urine and feces will be collected at different time points and the radioactivity will be measured. The recovery will be expressed as percentage of radioactivity administered
lambda-z
时间窗: up to 8 days
the apparent elimination rate constant
MRT
时间窗: up to 8 days
mean residence time
Ae(urine)
时间窗: up to 8 days
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
%Ae(urine)
时间窗: up to 8 days
the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose
CLr
时间窗: up to 8 days
renal clearance: the apparent volume of plasma cleared of Uproleselan per unit time via renal elimination, calculated as: CLr = Ae (urine) / AUC
Tmax
时间窗: up to 8 days
The time from dosing at which Cmax was apparent
AUC%extrap
时间窗: up to 8 days
percentage of AUC(0-inf) extrapolated beyond last measured time point
CI
时间窗: up to 8 days
clearance, the apparent volume cleared of parent drug per unit time after intravenous administration
Cmax
时间窗: up to 8 days
maximum observed concentration
AUC(0-inf)
时间窗: up to 8 days
area under the curve from 0 time extrapolated to infinity
AUC(0-last)
时间窗: up to 8 days
area under the curve from 0 time to last measurable concentration
T1/2
时间窗: up to 8 days
the apparent elimination half-life
Vx
时间窗: up to 8 days
the apparent volume of distribution after intravenous administration
次要结局
未报告次要终点