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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002895-29 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult formulation: Finerenone tablet_Fasting | Active Comparator | Single oral dose of 10 mg finerenone tablet fasting |
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| Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting | Experimental | Single oral dose of 5 x 0.25 mg finerenone oro-dispersible tablets fasting |
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| Pediatric formulation: 1.25 mg Finerenone ODT_Fasting | Experimental | Single oral dose of 1.25 mg finerenone oro-dispersible tablet fasting |
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| Pediatric formulation: 1.25 mg Finerenone ODT_Fed | Experimental | Single oral dose of 1.25 mg finerenone oro-dispersible tablet fed; 30 minutes after start of an American breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone (BAY94-8862): 1 0mg tablet | Drug | 10 mg finerenone immediate-release tablet; single dose in the fasting condition |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events as a measure of safety and tolerability | Up to 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
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| ID | Term |
|---|---|
| C576501 | finerenone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets | Drug | 5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition |
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| Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet | Drug | 1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition |
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