CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105, Germany
NCT Number: NCT04510987
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Kiel, Schleswig-Holstein, 24105, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects with renal impairment
Age-, gender, weight matched subjects
Tablet, oral
Tablet, oral
Time frame: Pre-dose until 96 hours after dosing
maximum observed drug concentration in measured matrix after single dose administration
Time frame: Pre-dose until 96 hours after dosing
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
maximum unbound drug concentration in plasma after single dose administration
Time frame: Pre-dose until 96 hours after dosing
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: Up to 3 days after last study medication
Bayer
Industry
Investigation of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of a Single Oral Dose of 25 mg BAY 2433334 in Male and Female Participants With Different Stages of Renal Impairment (Including on Dialysis), as Compared to Age, Gender and Weight Matched Participants in a Single-center, Non-randomized, Non-controlled, Non-blinded, Group Stratification Design Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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