Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of Increasing Single Oral Doses of BAY1834845 Including Relative Bioavailability of a Liquid Versus a Solid Dosage in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Maximum drug concentration in plasma after single dose administration (Cmax)
研究概览
简要总结
This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy male subject
- •Age: 18 to 50 years (inclusive) at the first screening visit
- •Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²
排除标准
- •Clinically relevant findings in the physical examination
- •Relevant diseases within the last 4 weeks prior to the first study drug administration
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration
研究组 & 干预措施
Dose escalation/BAY1834845
Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day
干预措施: BAY1834845 (Drug)
Placebo
Subjects will receive a single dose of placebo in the morning of the PK profile day
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum drug concentration in plasma after single dose administration (Cmax)
时间窗: Baseline to up to 14 days post drug administration
Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845
Severity of treatment-emergent adverse events
时间窗: Up to 25 days after last drug administration
The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe
Area under the plasma concentration vs. time curve (AUC)
时间窗: Baseline to up to 14 days post drug administration
AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast)
Frequency of treatment-emergent adverse events (TEAEs)
时间窗: Up to 25 days after last drug administration
AEs are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
次要结局
未报告次要终点