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

Sponsor
Bayer
Study ID
NCT04881994
Phase
PHASE1
Status
Completed

Conditions

  • Diabetic Nephropathy
  • Worsening Chronic Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 25, 2014
Status verified
Jul 2021
Primary completion
Sep 16, 2014
Completion
Dec 8, 2014

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Mild hepatic impairment (Child Pugh A)
    Participants with mild hepatic impairment (Child Pugh A) received single oral dose of finerenone.
  • Experimental: Moderate hepatic impairment (Child Pugh B)
    Participants with moderate hepatic impairment (Child Pugh B) received single oral dose of finerenone.
  • Experimental: Healthy participants
    Healthy age-, weight-, and gender- matched participants received single oral dose of finerenone.

Primary Outcome Measure

Area under the concentration versus time curve from zero to infinity (AUC) of finerenone in plasma [ Time Frame: 0 hour pre-dose to 96 hour post-dose ]

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