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

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.

Study Overview

• Status: Completed
• Conditions: Clinical Pharmacology
• Intervention / Treatment: Drug: Finerenone (BAY 94-8862) PEG solution; Drug: Eplerenone (Inspra®); Drug: Placebo; Drug: Finerenone (BAY 94-8862) immediate release tablet

Detailed Description

Clinical pharmacology

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Neuss, Nordrhein-Westfalen, Germany, 41460

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone (20 mg solution); 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.	Drug: Finerenone (BAY 94-8862) PEG solution; 2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862; Drug: Eplerenone (Inspra®); Single oral dose of 50 mg eplerenone; Drug: Placebo; Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Experimental: Finerenone (10 mg solution); 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.	Drug: Finerenone (BAY 94-8862) PEG solution; 2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862; Drug: Eplerenone (Inspra®); Single oral dose of 50 mg eplerenone; Drug: Placebo; Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Experimental: Finerenone (5 mg solution); 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.	Drug: Finerenone (BAY 94-8862) PEG solution; 2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862; Drug: Eplerenone (Inspra®); Single oral dose of 50 mg eplerenone; Drug: Placebo; Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Experimental: Finerenone (20 mg as tablets); 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.	Drug: Eplerenone (Inspra®); Single oral dose of 50 mg eplerenone; Drug: Placebo; Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step; Drug: Finerenone (BAY 94-8862) immediate release tablet; 20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets
Experimental: Finerenone (2.5 mg solution); 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.	Drug: Finerenone (BAY 94-8862) PEG solution; 2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862; Drug: Eplerenone (Inspra®); Single oral dose of 50 mg eplerenone; Drug: Placebo; Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2010
• Primary Completion (Actual): November 30, 2010
• Study Completion (Actual): May 17, 2011

Study Registration Dates

• First Submitted: August 18, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Healthy volunteers, proof-of-concept trial, PK and PD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antihypertensive Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Eplerenone
• Other Study ID Numbers: 13786; 2010-018500-90 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

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.