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A Study to Learn More About How Safe Nurandociguat is and How it Affects the Way the Body Processes Rosuvastatin and Dabigatran in Healthy Adults

Sponsor: Bayer

Summary

Researchers are looking for a better way to treat people who have chronic kidney disease. Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work as well as they should. People with CKD are at a higher risk of heart and blood vessel problems and often need medicines to manage their health. The study treatment nurandociguat (also called BAY 3283142) is a new medicine being developed to help people with CKD. It works by activating an enzyme called soluble guanylate cyclase (sGC), which helps relax blood vessels and may protect the kidneys. The study drug nurandociguat is thought to lower blood pressure and reduce kidney damage by improving blood flow and reducing stress on kidneys. In this study, participants will be healthy and will not benefit from administration of nurandociguat. However, the study will provide information on how to test Nurandociguat in future studies in people with chronic kidney disease. The main purpose of this study is to learn how safe nurandociguat is and how it affects the way the body processes (pharmacokinetics) two other medicines, rosuvastatin and dabigatran, in healthy adults. For this, researchers will collect: * the average highest level of rosuvastatin in the plasma (also called Cmax) * the average highest level of dabigatran in the plasma (also called Cmax) * the number of participants who have side effects during the study There are 2 groups in this study, one for rosuvastatin and one for dabigatran. The study participants will be assigned to a group based on the study plan. Each group will have 2 periods: Period 1 and Period 2. In period 1 a single dose of either rosuvastatin or dabigatran will be administered, and the breakdown of these 2 compounds will be investigated in the absence of nurandociguat. In period 2, nurandociguat will be given for 7 days at a low dose, followed by a single high dose on Day 8. On Day 8, a single dose of rosuvastatin and dabigatran, will be also administered to investigate their breakdown by the human body in the presence of nurandociguat. Each participant will be in the study for up to 7 weeks, including screening, treatment and follow up. During the study, study doctors will: * check vital signs (such as blood pressure and heart rate) * perform physical exams * take blood and urine samples for safety and to measure drug levels * do electrocardiograms (ECGs) * ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. The study doctors and their team will contact the participant study to learn about the participant's health until the participant completes the study.

Official title: An Open-label Study to Investigate the Influence of Nurandociguat on the Pharmacokinetics of Rosuvastatin and Dabigatran in Healthy Participants

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