A Phase I, Open-label Study of the Absorption, Metabolism and Excretion of Defactinib (VS-6063-106) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Urine amount excreted (Ae)
研究概览
简要总结
This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and metabolite identification of defactinib.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 18.0 to 35.0 kg/m2
- •History (Hx) regular bowel movements
- •Creatinine clearance >80 mL/min
排除标准
- •Hx alcohol abuse in past 2 yrs
- •Current smoker
- •Systolic blood pressure (S) or diastolic blood pressure (DBP) above upper limit of reference range (age 40-44 >90/140; age 45-65 >90/150)
研究组 & 干预措施
Defactinib treatment
Single dose of 400 mg [14C]-defactinib, oral suspension
干预措施: defactinib (Drug)
结局指标
主要结局
Urine amount excreted (Ae)
时间窗: Screening to 168h post-dose
Urine renal clearance (CLr)
时间窗: Screening to 168h post-dose
Faeces Ae
时间窗: Screening to 168h post-dose
Faeces Fe
时间窗: Screening to 168h post-dose
Urine fraction of the dose excreted (Fe)
时间窗: Screening to 168h post-dose
Urine cumulative amount excreted (Cum Ae)
时间窗: Screening to 168h post-dose
Urine cumulative fraction of the dose excreted (Cum Fe)
时间窗: Screening to 168h post-dose
Faeces Cum Ae
时间窗: Screening to 168h post-dose
Faeces Cum Fe
时间窗: Screening to 168h post-dose
All excreta Ae
时间窗: Screening to 168h post-dose
All excreta Fe
时间窗: Screening to 168h post-dose
All excreta Cum Ae
时间窗: Screening to 168h post-dose
All excreta Cum Fe
时间窗: Screening to 168h post-dose
All excreta non-renal clearance (CLnr)
时间窗: Screening to 168h post-dose
次要结局
- Percentage of AUC(0-inf) accounted for by extrapolation (AUC%extrap)(Screening to 168h post-dose)
- lamdba-z(Screening to 168h post-dose)
- Apparent elimination half-life (T1/2)(Screening to 168h post-dose)
- Mean residence time(Screening to 168h post-dose)
- Time at which the analyte is first quantifiable (Tlag)(Screening to 168h post-dose)
- Area under the concentration vs. time curve from time zero extrapolated to last measurable concentration (AUC(0-last))(Screening to 168h post-dose)
- Time from dosing at which Cmax is apparent (Tmax)(Screening to 168h post-dose)
- Maximum observed concentration (Cmax)(Screening to 168h post-dose)
- Apparent volume of distribution after oral administration (Vz/F)(Screening to 168h post-dose)
- Area under the concentration vs. time curve from time zero to infinity (AUC (0-inf))(Screening to 168h post-dose)
- Apparent clearance after oral administration (CL/F)(Screening to 168h post-dose)