Pharmacokinetics
Conditions
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 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.
Interventions
DRUGFinerenone (BAY94-8862): 1 0mg tablet
10 mg finerenone immediate-release tablet; single dose in the fasting condition
DRUGFinerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets
5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition
DRUGFinerenone (BAY94-8862): 1.25 mg oro-dispersible tablet
1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire | Up to 5 minutes after drug administration |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events as a measure of safety and tolerability | Up to 3 weeks |
Countries
Germany
Outcome results
None listed