NCT04881994

A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution

Investigation of the Pharmacokinetics, Safety, and Tolerability of Finerenone (BAY 94-8862) in Subjects With Hepatic Impairment (Classified as Child Pugh A or B) and in Age-, Weight-, and Gender-matched Healthy Subjects Following a Single Oral Dose in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic nephropathy, a long-term, progressive decrease in the kidneys' ability to work properly in patients with diabetes mellitus. In this study researchers wanted to learn more about a new substance called finerenone (BAY94-8862). Finerenone is a substance that blocks the activation of a protein in the body called mineralocorticoid receptor (MR). An increased activation of MR is involved in the development of hypertension, organ damage and worsening of heart failure. The researchers studied how finerenone moves into, through and out of the body. The researchers also looked at how safe finerenone is and how it affects the body. The main purpose of this study was to help researchers develop recommendations for the amount of the substance (the dosing) to be given to patients with reduced liver function.

Conditions

• Worsening Chronic Heart Failure
• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Finerenone (BAY94-8862)	Single oral dose of finerenone given as 5 mg immediate release (IR) tablet.

Timeline

• Start date: 2014-03-25
• Primary completion: 2014-09-16
• Completion: 2014-12-08
• First posted: 2021-05-11
• Last updated: 2021-07-16

Locations

1 site across 1 country: Germany