A Study to Learn How BAY94-8862 Moves Into, Through and Out of the Body, How Safe it is and How i… (NCT04908436) | Clinical Trial Compass
CompletedPhase 1
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
Germany33 participantsStarted 2010-10-27
Plain-language 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.
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.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion Criteria:
* The informed consent must be signed before any study specific tests or procedures are done;
* Male participants and female participants without childbearing potential (postmenopausal women with 12 month of spontaneous amenorrhea or with 6 month of spontaneous amenorrhea and serum follicle-stimulating hormone (FSH) levels \>30 mIU/mL; women with 6 weeks post bilateral ovarectomy, women with bilateral tubal ligation, and women with hysterectomy);
* Age: 18 to 79 years at the first screening examination;
* Race: White;
* Body mass index (BMI): ≥ 18 and ≤ 34 kg / m2;
Participants with renal impairment
* Creatinine clearance (CLCR) ≤ 80 mL/min determined from a 24 hour urine collection interval 2 - 14 days prior to dosing;
* Stable renal disease, ie a serum creatinine value determined at least 3-6 months before the pre-study visit should not vary by more than 20% from the serum creatinine value determined at the pre-study visit;
Healthy participants
\- Mean age and body weight in Group 1 (control group, healthy participants) and Groups 2 - 4 should not vary by more than +/- 10 years and +/- 10 kg, respectively.
Exclusion Criteria:
* Participation in another clinical trial during the preceding 3 months for multiple dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study);
* Exclusion periods from other studies or simultaneous participation in other clinical studies;
* Donation of more than…
What they're measuring
1
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)
Timeframe: Up to 96 hours post-dose
2
Maximum total (bound and unbound) drug concentration in plasma after single dose administration of BAY94-8862 (Cmax)