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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Finerenone (BAY94-8862): 1 0mg tablet
* Drug: Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets
* Drug: Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adult formulation: Finerenone tablet_Fasting<br>Single oral dose of 10 mg finerenone tablet fasting | Drug: Finerenone (BAY94-8862): 1 0mg tablet<br>* 10 mg finerenone immediate-release tablet; single dose in the fasting condition<br>|
| Experimental: Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting<br>Single oral dose of 5 x 0.25 mg finerenone oro-dispersible tablets fasting | Drug: Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets<br>* 5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition<br>|
| Experimental: Pediatric formulation: 1.25 mg Finerenone ODT_Fasting<br>Single oral dose of 1.25 mg finerenone oro-dispersible tablet fasting | Drug: Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet<br>* 1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition<br>|
| Experimental: Pediatric formulation: 1.25 mg Finerenone ODT_Fed<br>Single oral dose of 1.25 mg finerenone oro-dispersible tablet fed; 30 minutes after start of an American breakfast | Drug: Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet<br>* 1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finerenone area under the plasma concentration vs. time curve (AUC) |  | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours | 
| Finerenone maximum plasma concentration (Cmax) |  | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours | 
| Appearance of oro-dispersible tablets assessed by questionnaire |  | Up to 5 minutes after drug administration | 
| Taste of oro-dispersible tablets assessed by questionnaire |  | Up to 5 minutes after drug administration | 
| Texture of oro-dispersible tablets assessed by questionnaire |  | Up to 5 minutes after drug administration | 
| Smell of oro-dispersible tablets assessed by questionnaire |  | Up to 5 minutes after drug administration | 
| Overall impression of oro-dispersible tablets assessed by questionnaire |  | Up to 5 minutes after drug administration | 
| Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire |  | Up to 5 minutes after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events as a measure of safety and tolerability |  | Up to 3 weeks |