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

Sponsor
Bayer
Study ID
NCT04908436
Phase
PHASE1
Status
Completed

Conditions

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. 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. Many patients with worsening chronic heart failure also suffer from chronic kidney disease. Chronic kidney disease is a long-term decrease in the kidneys' ability to work properly. 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 kidney function.

Key Dates

Start date
Oct 27, 2010
Status verified
Jan 2022
Primary completion
May 5, 2011
Completion
Jan 27, 2012

Study Design

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

Arms

  • Experimental: Normal renal function
    Healthy participants with creatinine clearance (CLCR) \>80 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions.
  • Experimental: Mild renal impairment
    Participants with CLCR 50-80 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions.
  • Experimental: Moderate renal impairment
    Participants with CLCR 30-\<50 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions.
  • Experimental: Severe renal impairment
    Participants with CLCR \<30 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions.

Primary Outcome Measure

Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose administration of BAY94-8862 (AUC) [ Time Frame: Up to 96 hours post-dose ]

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