NCT04473651终止1 期
Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of participants with treatment emergent adverse events (Safety and Tolerability)
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.
详细描述
Part A: randomized, sequential
Part B: open-label, cross-over
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.
- •Other in- and exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Part A: Single dose of Lu AG06479 or Placebo
Experimental
干预措施: Lu AG06479 (Drug)
Part A: Single dose of Lu AG06479 or Placebo
Experimental
干预措施: Placebos (Drug)
Part B: Repeated dose of Lu AG06479 and Food interaction
Experimental
Sequence B1: Fed - Fasting - Fasting
Sequence B2: Fasting- Fed - Fasting
Sequence B3: Fasting- Fasting - Fed
干预措施: Lu AG06479 (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events (Safety and Tolerability)
时间窗: From baseline to Day 9 (Part A and B)
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)
次要结局
- CL/F Lu AG06479(From pre-dose to Day 5 (Part A and B))
- AUC (0-inf) of Lu AG06479(From pre-dose to Day 5 (Part A and B))
- Cmax Lu AG06479(From pre-dose to Day 5 (Part A and B))
研究者
研究点 (1)
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