Overview

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