Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Oral Dose of Finerenone 20 mg as Suspension (Pediatric Formulation), Intact Tablet and Crushed Tablet (Adult Formulation) in the Fasting Condition, and to Investigate the Effect of a High Fat, High Calorie Meal on the Suspension in Healthy Male Subjects in a Randomized, Open-label, Four-fold Crossover Design.

Bayer1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2016年11月17日最近更新: 2017年4月24日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 16
试验地点: 1
主要终点: Smell of oro-dispersible tablets assessed by questionnaire

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.

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: None

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 male subjects
•Age: 18 to 45 years (inclusive)
•Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m²
•Race: White

排除标准

•Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator
•A history of relevant diseases of vital organs, of the central nervous system or other organs
•Known renal or liver insufficiency
•Subjects with diagnosed malignancy, psychiatric disorders, or thyroid disorders (evaluated by medical history, physical examination, clinical symptoms, and assessment of thyroid stimulating hormone at screening)
•Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator
•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
•Relevant diseases within the last 4 weeks prior to the first study drug administration
•Smoking more than 10 cigarettes daily and/ or inability to refrain from smoking on the profile days until 8 h after administration
•Vegetarian or special diets preventing the subjects from eating the standard meals during the study, especially the high-fat high-calorie American breakfast or reluctance to ingest it

研究组 & 干预措施

Adult formulation: Finerenone tablet_Fasting

Active Comparator

Single oral dose of 20 mg intact finerenone tablet fasting

干预措施: Finerenone (BAY94-8862): 20 mg intact tablet (Drug)

Adult formulation: Finerenone crushed tablet_Fasting

Experimental

Single oral dose of 20 mg crushed and resuspended finerenone tablet fasting

干预措施: Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet (Drug)

Pediatric formulation: Finerenone suspension_Fasting

Experimental

Single oral dose of 20 mg finerenone suspension fasting

干预措施: Finerenone (BAY94-8862): 20 mg suspension (Drug)

Pediatric formulation: Finerenone suspension_Fed

Experimental

Single oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast

干预措施: Finerenone (BAY94-8862): 20 mg suspension (Drug)