check_circleStudy Completed
Worsening chronic heart failure, Diabetic nephropathy
Bayer Identifier:
14510
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
BothAge
18 - 79 YearsTrial summary
Enrollment Goal
27Trial Dates
March 2014 - December 2014Phase
Phase 1Could I Receive a placebo
NoProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kiel, 24105, Germany |
Primary Outcome
- Area under the concentration versus time curve from zero to infinity (AUC) of finerenone in plasmadate_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 plasmadate_rangeTime Frame:0 hour pre-dose to 96 hour post-dose
- Maximum observed drug concentration (Cmax) of finerenone in plasmadate_rangeTime Frame:0 hour pre-dose to 96 hour post-dose
- Maximum observed drug concentration of unbound finerenone (Cmax,u) in plasmadate_rangeTime Frame:0 hour pre-dose to 96 hour post-dose
Secondary Outcome
- Number of participants with adverse eventsdate_rangeTime Frame:From the start of study treatment up to 3 days after study treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3