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

• Status: Completed
• Trial end date: 2017-03-17
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

Criteria

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