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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Nurandociguat; Drug: Rosuvastatin; Drug: Dabigatran etexilate

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Clinical Research Services | Clinical Research Services Mannheim - Phase one unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 (rosuvastatin, nurandociguat + rosuvastatin); 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; Low dose once daily for 7 days, higher single dose; Drug: Rosuvastatin; Single dose (SD)
Experimental: Arm 2 (dabigatran etexilate, nurandociguat + dabigatran etexilate); 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; Low dose once daily for 7 days, higher single dose; Drug: Dabigatran etexilate; Single Dose (SD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of rosuvastatin		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	0-48 hours after administration of rosuvastatin in Day 1 of each treatment period
Cmax of unconjugated dabigatran		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	0-48 hours after administration of dabigatran etexilate in Day 1 of each treatment period

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2026
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Dabigatran; Rosuvastatin Calcium
• Other Study ID Numbers: 22600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No