Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body. Renal impairment which co-occurs in patients with heart failure is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it was tolerated and the way the body absorbed, distributed and excreted the study dug given as a single oral dose of 2.5 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight. The participants stayed at the trial site for about 6 days. During this time, the doctors took blood and urine samples and checked the participants' health. About 7-14 days after the participants took vericiguat (BAY1021189), the researchers checked the participants' health again and asked about any medical problems they had.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
39
Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)
Unnamed facility
Kiel, Schleswig-Holstein, Germany
AUC of vericiguat
Area under the concentration vs. time curve from zero to infinity after single dose administration
Time frame: Up to 96 hours
Cmax of vericiguat
Maximum observed drug concentration in measured matrix after single dose administration
Time frame: Up to 96 hours
AUC of vericiguat's metabolite M-1
Area under the concentration vs. time curve from zero to infinity after single dose administration
Time frame: Up to 96 hours
Cmax of vericiguat's metabolite M-1
Maximum observed drug concentration in measured matrix after single dose administration
Time frame: Up to 96 hours
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