A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion (ADME) of Oral [14C]-Ibrexafungerp in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mass balance
研究概览
简要总结
This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following administration in healthy male subjects.
Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.
详细描述
This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following administration in healthy male subjects.
Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.
All subjects will undergo preliminary screening procedures for the study at the screening visit. Subjects will be admitted to the clinical unit on the evening prior to dosing (Day -1). A single oral dose containing [14C]-ibrexafungerp oral solution will be administered to subjects. Individual subjects will be released from the clinical unit following study-related procedures on Days 8 to 20 according to their % of radioactivity collected in relation to the dose administered.
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
- •Healthy males
- •Age 30 to 65 years of age at the time of signing informed consent
- •Must be willing and able to participate in the whole study
- •Must provide written informed consent
- •Must agree to adhere to the contraception requirements
排除标准
- •Subjects who have received any investigational drug in a clinical research study within the 90 days prior to Day 1
- •Current smokers
- •Recent radiation exposure
- •Subjects who have been enrolled in a 14C ADME study in the last 12 months
- •An acute or chronic disease determined by the investigator to be clinically significant
- •Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis at screening as judged by the investigator
- •Evidence of renal impairment at screening
- •History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
研究组 & 干预措施
Ibrexafungerp
Oral [14C]-Ibrexafungerp Single Dose
干预措施: [14C]-Ibrexafungerp (Drug)
结局指标
主要结局
Mass balance
时间窗: Day 20
Amount recovered expressed as a percentage of the dose administered
次要结局
- Number of subjects with treatment-emergent adverse events(Day 20)
- Routes and rates of elimination of [14C]-ibrexafungerp(Day 20)