Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862

Study to Investigate the Effectiveness of Different Single Oral Doses of BAY94-8862 on Natriuresis After Administration of 0.5 mg Fludrocortisone (Astonin H®) With 50 mg Eplerenone (Inspra®) as Active Control in Healthy Male Subjects in a Randomized, Single-blind, Placebo-controlled, Combined 3-fold Crossover and Parallel-group Design

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01473108

Enrollment

Registered

2011-11-17

Start date

2010-03-29

Completion date

2011-05-17

Last updated

2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Pharmacology

Keywords

Healthy volunteers, proof-of-concept trial, PK and PD

Brief summary

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.

Detailed description

Clinical pharmacology

Interventions

DRUGFinerenone (BAY 94-8862) PEG solution

2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862

DRUGFinerenone (BAY 94-8862) immediate release tablet

20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets

DRUGEplerenone (Inspra®)

Single oral dose of 50 mg eplerenone

DRUGPlacebo

Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 46 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male white subjects * 18 to 46 years of age * Body mass index (BMI): 18 - 29.9 kg/m²

Exclusion criteria

* Clinically relevant findings in medical history or in the physical examination * Systolic blood pressure below 100 or above 140 mmHg * Diastolic blood pressure below 50 or above 90 mmHg * Heart rate below 45 or above 95 beats / min

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame
Number of participants with adverse events	Up to 28 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026