Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers

Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single Oral Doses of Finerenone 1.25 mg and 5 x 0.25 mg Orodispersible Tablet (Pediatric Formulation) in Comparison to 10 mg Tablet (Adult Formulation) in the Fasting Condition and to Investigate the Effect of a High Fat, High Calorie Meal on 1.25 mg Oro-dispersible Tablet in Healthy Male Subjects in a Randomized, Open-label, Four-fold Crossover Design

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 single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel orodispersible tablet formulation for the treatment of children, in comparison to the adult tablet formulation.

Inclusion Criteria:

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

Exclusion Criteria:

• 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