Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Cmax of Lu AF11167
研究概览
简要总结
The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women
详细描述
This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2
- •(Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status
排除标准
- •The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Part A
干预措施: Lu AF11167 (Drug)
Part B group 1
Treatment period 1: Fasted + iv;
Treatment period 2: Fasted;
Treatment period 3: High-fat meal
干预措施: [14C]-Lu AF11167 (Drug)
Part B group 1
Treatment period 1: Fasted + iv;
Treatment period 2: Fasted;
Treatment period 3: High-fat meal
干预措施: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) (Drug)
Part B group 2
Treatment period 1: High-fat meal;
Treatment period 2: Fasted + iv;
Treatment period 3: Fasted
干预措施: [14C]-Lu AF11167 (Drug)
Part B group 2
Treatment period 1: High-fat meal;
Treatment period 2: Fasted + iv;
Treatment period 3: Fasted
干预措施: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) (Drug)
Part B group 3
Treatment period 1: Fasted;
Treatment period 2: High-fat meal;
Treatment period 3: Fasted + iv
干预措施: [14C]-Lu AF11167 (Drug)
Part B group 3
Treatment period 1: Fasted;
Treatment period 2: High-fat meal;
Treatment period 3: Fasted + iv
干预措施: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) (Drug)
结局指标
主要结局
Cmax of Lu AF11167
时间窗: From 0 to 48 hours
Maximum observed plasma concentration
AUC(0-inf) of Lu AF11167
时间窗: From 0 to 48 hours
Area under the plasma concentration time curve from zero to infinity
Relative bioavailability F(rel) of Lu AF11167
时间窗: From 0 to 48 hours
F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only)
Absolute bioavailability F(abs) of Lu AF11167
时间窗: From 0 to 48 hours
F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only)
次要结局
未报告次要终点