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.
- Healthy male subjects - Age: 18 to 45 years (inclusive) - Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m² - Race: White
- 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
Berlin, Germany, 13353
E-mail: [email protected]
Phone: Not Available
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.