A Phase 1 interventional study of Nurandociguat and Rosuvastatin in Chronic Kidney Disease, sponsored by Bayer. Withdrawn at 1 site in Germany. Open to participants aged 18 Years to 58 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Bayer · Phase 1, Interventional, and Basic science
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:
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:
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.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
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Exclusion Criteria:
Participants will receive a single dose of rosuvastatin in Period 1. In Period 2, participants will take nurandociguat once daily for 7 days, followed by a single higher dose of nurandociguat and a single dose of rosuvastatin on Study Day 8.
Drug: Nurandociguat · Drug: Rosuvastatin
Participants will receive a single dose of dabigatran etexilate in Period 1. In Period 2, participants will take nurandociguat once daily for 7 days, followed by a single higher dose of nurandociguat and a single dose of dabigatran etexilate on Study Day 8.
Drug: Nurandociguat · Drug: Dabigatran etexilate
Low dose once daily for 7 days, higher single dose
Single dose (SD)
Single Dose (SD)
Cmax of rosuvastatin
Time frame: 0-48 hours after administration of rosuvastatin in Day 1 of each treatment period
AUC of rosuvastatin
If AUC cannot be determined reliably in all participants, AUC(0-tlast) will be used instead of AUC
Time frame: 0-48 hours after administration of rosuvastatin in Day 1 of each treatment period
Cmax of unconjugated dabigatran
Time frame: 0-48 hours after administration of dabigatran etexilate in Day 1 of each treatment period
AUC of unconjugated dabigatran
If AUC cannot be determined reliably in all participants, AUC(0-tlast) will be used instead of AUC
Time frame: 0-48 hours after administration of dabigatran etexilate in Day 1 of each treatment period
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From the start of study intervention up to 7 days after the last study intervention administration
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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