check_circleStudy Completed

Worsening chronic heart failure, Diabetic nephropathy

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

Trial purpose

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 Participants Requirements

Sex

Both

Age

18 - 79 Years

Trial summary

Enrollment Goal
27
Trial Dates
March 2014 - December 2014
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Kiel, 24105, Germany

Primary Outcome

  • Area under the concentration versus time curve from zero to infinity (AUC) of finerenone in plasma
    date_rangeTime Frame:
    0 hour pre-dose to 96 hour post-dose
  • Area under the concentration versus time curve from zero to infinity of unbound finerenone (AUCu) in plasma
    date_rangeTime Frame:
    0 hour pre-dose to 96 hour post-dose
  • Maximum observed drug concentration (Cmax) of finerenone in plasma
    date_rangeTime Frame:
    0 hour pre-dose to 96 hour post-dose
  • Maximum observed drug concentration of unbound finerenone (Cmax,u) in plasma
    date_rangeTime Frame:
    0 hour pre-dose to 96 hour post-dose

Secondary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    From the start of study treatment up to 3 days after study treatment

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3