Study to Investigate the Effectiveness of Different Single Oral Doses of BAY94-8862 on Natriuresis After Administration of 0.5 mg Fludrocortisone (Astonin H®) With 50 mg Eplerenone (Inspra®) as Active Control in Healthy Male Subjects in a Randomized, Single-blind, Placebo-controlled, Combined 3-fold Crossover and Parallel-group Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 67
- 主要终点
- Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)
研究概览
简要总结
Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.
详细描述
Clinical pharmacology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male white subjects
- •18 to 46 years of age
- •Body mass index (BMI): 18 - 29.9 kg/m²
排除标准
- •Clinically relevant findings in medical history or in the physical examination
- •Systolic blood pressure below 100 or above 140 mmHg
- •Diastolic blood pressure below 50 or above 90 mmHg
- •Heart rate below 45 or above 95 beats / min
研究组 & 干预措施
Finerenone (20 mg solution)
3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Finerenone (BAY 94-8862) PEG solution (Drug)
Finerenone (20 mg solution)
3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Eplerenone (Inspra®) (Drug)
Finerenone (20 mg solution)
3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Placebo (Drug)
Finerenone (10 mg solution)
3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Finerenone (BAY 94-8862) PEG solution (Drug)
Finerenone (10 mg solution)
3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Eplerenone (Inspra®) (Drug)
Finerenone (10 mg solution)
3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Placebo (Drug)
Finerenone (5 mg solution)
3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Finerenone (BAY 94-8862) PEG solution (Drug)
Finerenone (5 mg solution)
3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Eplerenone (Inspra®) (Drug)
Finerenone (5 mg solution)
3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Placebo (Drug)
Finerenone (20 mg as tablets)
3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Finerenone (BAY 94-8862) immediate release tablet (Drug)
Finerenone (20 mg as tablets)
3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Eplerenone (Inspra®) (Drug)
Finerenone (20 mg as tablets)
3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Placebo (Drug)
Finerenone (2.5 mg solution)
3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Finerenone (BAY 94-8862) PEG solution (Drug)
Finerenone (2.5 mg solution)
3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Eplerenone (Inspra®) (Drug)
Finerenone (2.5 mg solution)
3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)
时间窗: Up to 26 hours post-dose
AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone)
时间窗: Up to 60 hours after administration
Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone)
时间窗: Up to 60 hours after administration
次要结局
- Number of participants with adverse events(Up to 28 days)