Chronic Kidney Disease
Conditions
Brief 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.
Interventions
DRUGNurandociguat
Low dose once daily for 7 days, higher single dose
DRUGRosuvastatin
Single dose (SD)
DRUGDabigatran etexilate
Single Dose (SD)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 58 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must be 18 to 58 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, vital signs (blood pressure and heart rate), ECG, body temperature, and clinical laboratory tests. * Body weight of at least 60 kg and BMI within the range 18.0 - 29.9 kg/m2(inclusive) at screening. * Contraceptive use by the participant or the participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention(s) will not be normal. * Known severe allergies, e.g., allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions. * Acute diarrhea or constipation within 14 days before the first administration of study intervention. * Contraindications to rosuvastatin or dabigatran etexilate. * Regular use of prescription drugs (other than hormonal contraceptives), over-the-counter drugs, supplements (e.g., carnitine products, or high dose vitamins), anabolics or herbal products within the last 14 days before the first administration of study intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of rosuvastatin | 0-48 hours after administration of rosuvastatin in Day 1 of each treatment period | — |
| AUC of rosuvastatin | 0-48 hours after administration of rosuvastatin in Day 1 of each treatment period | If AUC cannot be determined reliably in all participants, AUC(0-tlast) will be used instead of AUC |
| Cmax of unconjugated dabigatran | 0-48 hours after administration of dabigatran etexilate in Day 1 of each treatment period | — |
| AUC of unconjugated dabigatran | 0-48 hours after administration of dabigatran etexilate in Day 1 of each treatment period | If AUC cannot be determined reliably in all participants, AUC(0-tlast) will be used instead of AUC |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | From the start of study intervention up to 7 days after the last study intervention administration |
Countries
Germany
Outcome results
None listed