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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018500-90 | EudraCT Number |
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Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.
Clinical pharmacology
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finerenone (20 mg solution) | Experimental | 3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
|
| Finerenone (10 mg solution) | Experimental | 3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
|
| Finerenone (5 mg solution) | Experimental | 3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
|
| Finerenone (20 mg as tablets) | Experimental | 3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone (BAY 94-8862) PEG solution | Drug | 2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862 |
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| Measure | Description | Time Frame |
|---|---|---|
| Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis) | Up to 26 hours post-dose | |
| AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone) | Up to 60 hours after administration | |
| Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone) | Up to 60 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 28 days |
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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 |
|---|---|---|---|---|---|---|
| Neuss | North Rhine-Westphalia | 41460 | Germany |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| ID | Term |
|---|---|
| C576501 | finerenone |
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Finerenone (2.5 mg solution) | Experimental | 3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
|
| Finerenone (BAY 94-8862) immediate release tablet | Drug | 20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets |
|
| Eplerenone (Inspra®) | Drug | Single oral dose of 50 mg eplerenone |
|
| Placebo | Drug | Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step |
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |