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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 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
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
结局指标
主要结局
Smell of oro-dispersible tablets assessed by questionnaire
时间窗: Up to 5 minutes after drug administration
Finerenone maximum plasma concentration (Cmax)
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Finerenone area under the plasma concentration vs. time curve (AUC)
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Appearance of oro-dispersible tablets assessed by questionnaire
时间窗: Up to 5 minutes after drug administration
Overall impression of oro-dispersible tablets assessed by questionnaire
时间窗: Up to 5 minutes after drug administration
Taste of oro-dispersible tablets assessed by questionnaire
时间窗: Up to 5 minutes after drug administration
Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire
时间窗: Up to 5 minutes after drug administration
Texture of oro-dispersible tablets assessed by questionnaire
时间窗: Up to 5 minutes after drug administration
次要结局
- Number of patients with adverse events as a measure of safety and tolerability(Up to 4 weeks)