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.

Bayer1 site in 1 country16 target enrollmentStarted: November 17, 2016Last updated: April 24, 2017

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor
Enrollment: 16
Locations: 1
Primary Endpoint: Smell of oro-dispersible tablets assessed by questionnaire

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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 novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Other
Masking: None

Eligibility Criteria

Ages: 18 Years to 45 Years (Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

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

Arms & Interventions

Adult formulation: Finerenone tablet_Fasting

Active Comparator

Single oral dose of 20 mg intact finerenone tablet fasting

Intervention: Finerenone (BAY94-8862): 20 mg intact tablet (Drug)

Adult formulation: Finerenone crushed tablet_Fasting

Experimental

Single oral dose of 20 mg crushed and resuspended finerenone tablet fasting

Intervention: Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet (Drug)

Pediatric formulation: Finerenone suspension_Fasting

Experimental

Single oral dose of 20 mg finerenone suspension fasting

Intervention: Finerenone (BAY94-8862): 20 mg suspension (Drug)

Pediatric formulation: Finerenone suspension_Fed

Experimental

Single oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast

Intervention: Finerenone (BAY94-8862): 20 mg suspension (Drug)