An Open Label, Single-Period Repeated Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Pitolisant, at Steady-State Conditions, in Healthy CYP2D6 Genotyped Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bioprojet
- 入组人数
- 8
- 主要终点
- Apparent clearance (Clss/F), pitolisant and major metabolites.
研究概览
简要总结
The purpose of this study is to better define the absorption and elimination pathways, and circulating metabolites of Pitolisant at steady state using Pitolisant radiolabelled, in healthy CYP2D6 genotyped male subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 aged 30 to 65 years.
- •Body mass index 18.0 to 35.0 kg/m
- •Genotyped with regard to their CYP2D6 status.
排除标准
- •Participation in a clinical research study within the previous 3 months
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
- •Regular alcohol consumption in males >21 units per week.
- •Current smokers and those who have smoked within the last 12 months.
- •Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation.
- •Use of CYP2D6 inhibitors or inducers in the 28 days prior to IMP administration
研究组 & 干预措施
Pitolisant
Pitolisant, oral single dose administration, from Day1 to Day7.
干预措施: Pitolisant (Drug)
[14C]-Pitolisant
[14C]-Pitolisant, oral single dose administration at Day8.
干预措施: [14C]-Pitolisant (Radiation)
结局指标
主要结局
Apparent clearance (Clss/F), pitolisant and major metabolites.
时间窗: From Day 1 (pre-dose) until 168hours post last dose
The slope of the apparent elimination phase (lambda-z), pitolisant and major metabolites.
时间窗: From Day 1 (pre-dose) until 168hours post last dose
The apparent elimination half-life (T½), pitolisant and major metabolites.
时间窗: From Day 1 (pre-dose) until 168hours post last dose
Mass balance recovery of total radioactivity (Ae) in urine, faeces and expired air.
时间窗: from Day 8 (pre-dose) to 120 h post 14C-radioactivity dose
Peak Plasma Concentration (Cmax), pitolisant and major metabolites.
时间窗: From Day 1 (pre-dose) until 168hours post last dose
Volume of distribution (Vz/F), pitolisant and major metabolites.
时间窗: From Day 1 (pre-dose) until 168hours post last dose
Time to reach Cmax (Tmax), pitolisant and major metabolites.
时间窗: From Day 1 (pre-dose) until 168hours post last dose
Area under the plasma concentration versus time curve [AUC(0-tau), AUC(0-inf), %AUCextrap], pitolisant and major metabolites.
时间窗: From Day 1 (pre-dose) until 168hours post last dose
次要结局
未报告次要终点