Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure). Liver impairment is a condition in which the liver is not working as well as they should. The goal of the study is to learn more about the safety of neladenoson bialanate, how it is tolerated and the way the body absorbs, distributes and excretes the study dug given as a single oral dose neladenoson bialanate in participants with liver impairment and healthy participants matched for age-, gender-, and weight
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
fu for BAY 84-3174
Fraction of free (unbound) drug in plasma or serum after single dose administration
Time frame: At 4 hours after study drug administration
AUC for BAY 84-3174
Area under the concentration vs. time curve from zero to infinity after single dose administration
Time frame: Pre-dose up to 49 days after study drug administration
AUCu for BAY 84-3174
AUC of unbound drug after single dose administration
Time frame: Pre-dose up to 49 days after study drug administration
AUCnorm for BAY 84-3174
AUC divided by dose per body weight after single dose administration
Time frame: Pre-dose up to 49 days after study drug administration
Cmax for BAY 84-3174
Maximum observed drug concentration in measured matrix after single dose administration
Time frame: Pre-dose up to 49 days after study drug administration
Cmax,u for BAY 84-3174
Cmax of unbound drug after single dose administration
Time frame: Pre-dose up to 49 days after study drug administration
Cmax,norm for BAY 84-3174
Cmax divided by dose per body weight after single dose administration
Time frame: Pre-dose up to 49 days after study drug administration
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: Up to 49 days after study drug administration
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