Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •The informed consent must be signed before any study specific tests or procedures are done.
- •Healthy male subject.
- •Age: 18 to 45 years (inclusive) at the screening.
- •Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m
- •Ability to understand and follow study-related instructions.
排除标准
- •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.
- •Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
- •Regular use of medicines.
- •Smoking more than 10 cigarettes daily.
- •Systolic blood pressure below 100 or above 145 mmHg (at screening).
- •Diastolic blood pressure below 50 or above 90 mmHg (at screening).
- •Heart rate below 50 or above 90 beats/ min (at screening).
研究组 & 干预措施
Single/ multiple doses of 40 mg BAY1101042 or placebo
Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: Placebo (Drug)
Single/multiple doses of 10 mg BAY1101042 or placebo
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: BAY1101042 (Drug)
Single/multiple doses of 10 mg BAY1101042 or placebo
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: Placebo (Drug)
Single/ multiple doses of 20 mg BAY1101042 or placebo
Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: BAY1101042 (Drug)
Single/ multiple doses of 20 mg BAY1101042 or placebo
Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: Placebo (Drug)
Single/ multiple doses of 30 mg BAY1101042 or placebo
Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: BAY1101042 (Drug)
Single/ multiple doses of 30 mg BAY1101042 or placebo
Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: Placebo (Drug)
Single/ multiple doses of 40 mg BAY1101042 or placebo
Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: BAY1101042 (Drug)
Single/ multiple doses of 50 mg BAY1101042 or placebo
Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: BAY1101042 (Drug)
Single/ multiple doses of 50 mg BAY1101042 or placebo
Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
干预措施: Placebo (Drug)
Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo
Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days
干预措施: BAY1101042 (Drug)
Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo
Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: Approximately 19 days
Assessment of treatment emergent adverse events from first study drug intake until follow up
次要结局
- Cmax,md/D of BAY1101042(At day 9)
- AUC(0-24) of BAY1101042(At day 1)
- Cmax/D of BAY1101042(At day 1)
- AUCτ,md of BAY1101042(At day 9)
- Cmax,md of BAY1101042(At day 9)
- AUCτ,md/D of BAY1101042(At day 9)
- AUC(0-24)/D of BAY1101042(At day 1)
- Cmax of BAY1101042(At day 1)