A Phase 1, Randomised, Oral Dose Trial to Evaluate the Effect of Food on LEO 152020 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- AUC (0 to infinity)
研究概览
简要总结
A phase 1 trial in healthy people to evaluate the food effect on LEO 152020 in an open-label design using film-coated tablets
详细描述
This trial will evaluate the pharmacokinetics and tolerability of 2 single doses of film-coated tablets in the morning after fasting or after a high-fat breakfast. The 2 doses will be separated by a washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fed
Single oral dose given after a full breakfast
干预措施: LEO 152020 Tablet (Drug)
Fasting
Single oral dose given in fasting state
干预措施: LEO 152020 Tablet (Drug)
结局指标
主要结局
AUC (0 to infinity)
时间窗: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf)
Cmax
时间窗: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Maximum observed plasma concentration
次要结局
- Number of subjects with clinically relevant changes in vital signs (pulse)(Baseline to Day 10)
- Number of subjects with laboratory abnormalities in chemistry parameters(Baseline to Day 10)
- Number of subjects with abnormal ECGs(Baseline to Day 10)
- tmax(pre-dose to 48 hours of each treatment period (Day 1 and Day 8))
- t 1/2(pre-dose to 48 hours of each treatment period (Day 1 and Day 8))
- Number of total adverse events (AEs) and number of subjects with AEs at each combination of treatment and period(Baseline to Day 10)
- Number of subjects with clinically relevant changes in vital signs (resting blood pressure)(Baseline to Day 10)
- Number of subjects with clinically relevant changes in vital signs (oral body temperature)(Baseline to Day 10)
- AUC (0 to last)(pre-dose to 48 hours of each treatment period (Day 1 and Day 8))
- Number of subjects with laboratory abnormalities in haematology parameters(Baseline to Day 10)
- Number of subjects with laboratory abnormalities in urinalysis parameters(Baseline to Day 10)