A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism and Excretion (ADME) of Oral [14^C]-Ibrexafungerp in Healthy Male Subjects After Repeat Dosing
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
- Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp
研究概览
简要总结
This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.
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 aged 30 to 65 years willing and able to sign and informed consent.
排除标准
- •Clinically significant medical history or concurrent medical conditions included but not limited to infections, liver or kidney disease
- •Use of certain concomitant medications
- •History of smoking or alcohol abuse
研究组 & 干预措施
Single dose of [14^C]-Ibrexafungerp
Each subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total.
干预措施: Ibrexafungerp (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp
时间窗: Day1 and Day 4
Area under the plasma concentration versus time curve (AUC) will be estimated where possible
Mass balance recovery
时间窗: Day 26
Mass balance recovery of total radioactivity in urine, faeces and all excreta (urine and faeces): cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Area under the plasma concentration versus time curve (AUC) of total radioactivity
时间窗: Day 1 and Day 4
Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible
Peak Plasma Concentration (Cmax) of Ibrexafungerp
时间窗: Day 1 and Day 4
Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated
Metabolite identification in plasma, urine and faeces
时间窗: Day 26
Determination of primary metabolites using liquid chromatography-radio-detection
次要结局
- Routes and rates of elimination of [14^C]-Ibrexafungerp(Day 26)
- Distribution of total radioactivity into blood cells(Day 4)
- Safety of Ibrexafungerp(Day 4)