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

Phase 1

Completed

• Conditions: Clinical Pharmacology
• Interventions: Drug: Finerenone (BAY 94-8862) PEG solution; Drug: Finerenone (BAY 94-8862) immediate release tablet; Drug: Eplerenone (Inspra®); Drug: Placebo

• Registration Number: NCT01473108
• Lead Sponsor: Bayer

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

Study Timeline

• Study Start: 2010-03-29
• Primary Completion: 2010-11-30
• Study Completion: 2011-05-17
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 67

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Finerenone (2.5 mg solution)	Finerenone (BAY 94-8862) PEG 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.
Finerenone (5 mg solution)	Finerenone (BAY 94-8862) PEG 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.
Finerenone (10 mg solution)	Finerenone (BAY 94-8862) PEG 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.
Finerenone (20 mg as tablets)	Finerenone (BAY 94-8862) immediate release tablet	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.
Finerenone (20 mg solution)	Placebo	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)	Eplerenone (Inspra®)	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)	Eplerenone (Inspra®)	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 (2.5 mg solution)	Eplerenone (Inspra®)	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 (2.5 mg solution)	Placebo	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 (20 mg solution)	Finerenone (BAY 94-8862) PEG 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.
Finerenone (20 mg solution)	Eplerenone (Inspra®)	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 (5 mg solution)	Placebo	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 (10 mg solution)	Placebo	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 (20 mg as tablets)	Eplerenone (Inspra®)	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.
Finerenone (20 mg as tablets)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of participants with adverse events	Up to 28 days