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A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants

Bayer · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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chronic-kidney-diseasehealthy-volunteers
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to work properly. The study treatment BAY3283142 is under development for treating CKD. It works by activating a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD. The participants of this study will be healthy and will have no benefit from the intake of the study treatment. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD. The main purpose of this study is to learn how safe the study treatment BAY3283142 is and how it affects the body in comparison to placebo when given as single and multiple amounts in healthy male participants in Japan. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To do this, the study team will compare the number of participants who have medical problems after taking BAY3283142 with those participants who take placebo. These medical problems are called adverse events. The study doctors and their team keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Another purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body. To answer this, the study doctors and their team will take blood samples from the participants and measure: * The average highest level of BAY3283142 in the blood (also called Cmax) * The average total level of BAY3283142 in the blood (also called AUC). Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once a day. A group of participants will start out by receiving a low amount of the study treatment. The st
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