NCT03540615已完成1 期
Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Increasing Single Oral Doses of BAY1830839 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Cmax of BAY1830839 in plasma
研究概览
简要总结
The primary objectives of this study are to investigate
- the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions
- the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) : ≥18.5 and ≤30 kg/m*2
排除标准
- •Relevant diseases within the last 4 weeks prior to the first study drug administration
- •Febrile illness within 4 weeks before the first study drug administration
- •Known hypersensitivity to the study drugs or components of the preparations
- •Clinically relevant findings in the physical examination
研究组 & 干预措施
BAY1830839
Experimental
Single Dose escalations
干预措施: BAY1830839 (Drug)
Placebo
Placebo Comparator
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cmax of BAY1830839 in plasma
时间窗: Day 1, 2, 3, 4, 6 ,7, 9, and 12
maximum observed drug concentration in plasma after single dose administration
Severity of treatment-emergent adverse events
时间窗: From first application of study intervention up to 30 days after end of treatment
Frequency of treatment-emergent adverse events
时间窗: From first application of study intervention up to 30 days after end of treatment
AUC of BAY1830839 in plasma
时间窗: Day 1, 2, 3, 4, 6 ,7, 9, and 12
AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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