BAY2433334 is under clinical development for prevention of complications in diseases such as heart attack, irregular heart beat or stroke which can arise by formation of blood clots elsewhere in the body and travels through the blood stream to plug another vessel. Renal impairment which co-occurs in elderly and patients with heart attack, irregular heart beat or stroke is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study is to learn more about the safety of BAY2433334, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 25 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Tablet, oral
Tablet, oral
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Cmax
maximum observed drug concentration in measured matrix after single dose administration
Time frame: Pre-dose until 96 hours after dosing
AUC
area under the concentration vs. time curve from zero to infinity after single (first) dose AUC(0-tlast) and AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
Time frame: Pre-dose until 96 hours after dosing
Cmax,u
maximum unbound drug concentration in plasma after single dose administration
Time frame: Pre-dose until 96 hours after dosing
AUCu
area under the unbound plasma concentration vs time curve from zero to infinity after single (first) dose AUC(0-tlast) and AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
Time frame: Pre-dose until 96 hours after dosing
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to 3 days after last study medication
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