A Study to Learn About How a New Nurandociguat Tablet is Absorbed and Processed in the Body Compared to an Old Tablet and How Food Affects the Way the New Tablet is Absorbed and Processed in the Body

A Single Center, Open-label Study Assessing the Relative Bioavailability of a New Nurandociguat Tablet Formulation Versus an Existing Formulation and Investigating the Food Effect of the New Tablet Formulation

Researchers conduct this clinical study to learn more about a new tablet of a medicine called nurandociguat. Nurandociguat is being developed as a possible treatment for people with chronic kidney disease (CKD) which is a long-term condition in which the ability of the kidneys to properly function decreases over time. It is often caused by high blood glucose levels.

The main purposes of the study are

• To learn how the new nurandociguat tablet is absorbed and processed in the body (which is also known as "pharmacokinetics [PK]" measurement) compared to an old tablet when taken without food.
• To learn how food affects the way the new tablet is absorbed and processed in the body when taken with a high-fat, high-calorie meal (like a big breakfast).

To do this, researchers will take blood samples from the participants and measure:

• Maximum observed concentration (Cmax): the highest concentration of nurandociguat in participants' plasma
• Area under the concentration time curve (AUC): the total amount of nurandociguat in participants' plasma over time Another purpose of this study is to learn how safe the new nurandociguat tablet is. Therefore researchers will monitor the number of participants who experience medical problems during this study. These medical problems are called adverse events.

Only healthy participants are taking part in this study. During the study, participants will receive 2 different types of nurandociguat tablets. These include the newly developed tablet and an existing tablet that has already been used in previous clinical studies. Each participant will receive 3 different treatments:

• Treatment A: Nurandociguat old tablet, taken without food
• Treatment B: Nurandociguat new tablet, taken without food
• Treatment C: Nurandociguat new tablet, taken with food Researchers have proposed 5 optional dosing schemes for this clinical study, however only one scheme will be selected based on the findings from an ongoing clinical study. Afterwards, the study will start.
• For Optional Scheme 1-3, each participant will receive the three treatments A, B, and C, one at a time, in a different order for each participant with a break of at least 7 days between treatments.
• The Optional Schemes 4-5 follow a fixed sequence design. Each participant will first receive the nurandociguat new tablet formulation at a lower dose for 7 days, then receive the higher dose for in total 11 days. The higher dose will be administered for 5 days using the old tablet formulation followed by 6 days using the new tablet formulation. PK measurement will be assessed after 5 days of treatment with the old tablet formulation (without food), after 5 days of treatment with the new tablet formulation (without food) and after 6 days of treatment with the new tablet formulation (with food).

The researchers will closely monitor and manage any medical problems that the participants may have during the study.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Nurandociguat (BAY3283142) old tablet - SD; Drug: Nurandociguat (BAY3283142) new tablet - SD; Drug: Nurandociguat (BAY3283142) old tablet; Drug: Nurandociguat (BAY3283142) new tablet

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: 0018888422937; Email: clinical-trials-contact@bayer.com

Study Locations

• Germany
  • Berlin, Germany, 13627
    • Recruiting
    • CRS Clinical Research Services Berlin GmbH

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), electrocardiogram (ECG), body temperature, and laboratory tests.
• Body Mass Index (BMI) within the range 18.0 and 29.9 kg/m^2 (inclusive).
• Body weight above or equal 60 kg.
• Male and female.

Exclusion Criteria:

• Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.
• Acute diarrhea or constipation within 14 days before the first intake of study intervention.
• Regular use of medicines within the last 14 days before the first study intervention administration.
• Special diets preventing the participants from eating the standard meals during the study.
• Participant is unable or unwilling to comply with study restrictions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optional Scheme 1-3: Treatment A-B-C; Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration.	Drug: Nurandociguat (BAY3283142) old tablet - SD; Single dose (SD) in treatment A.; Drug: Nurandociguat (BAY3283142) new tablet - SD; Single dose (SD) in treatment B and C.
Experimental: Optional Scheme 1-3: Treatment A-C-B; Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration.	Drug: Nurandociguat (BAY3283142) old tablet - SD; Single dose (SD) in treatment A.; Drug: Nurandociguat (BAY3283142) new tablet - SD; Single dose (SD) in treatment B and C.
Experimental: Optional Scheme 1-3: Treatment B-A-C; Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration.	Drug: Nurandociguat (BAY3283142) old tablet - SD; Single dose (SD) in treatment A.; Drug: Nurandociguat (BAY3283142) new tablet - SD; Single dose (SD) in treatment B and C.
Experimental: Optional Scheme 1-3: Treatment B-C-A; Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration.	Drug: Nurandociguat (BAY3283142) old tablet - SD; Single dose (SD) in treatment A.; Drug: Nurandociguat (BAY3283142) new tablet - SD; Single dose (SD) in treatment B and C.
Experimental: Optional Scheme 1-3: Treatment C-A-B; Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration.	Drug: Nurandociguat (BAY3283142) old tablet - SD; Single dose (SD) in treatment A.; Drug: Nurandociguat (BAY3283142) new tablet - SD; Single dose (SD) in treatment B and C.
Experimental: Optional Scheme 1-3: Treatment C-B-A; Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration.	Drug: Nurandociguat (BAY3283142) old tablet - SD; Single dose (SD) in treatment A.; Drug: Nurandociguat (BAY3283142) new tablet - SD; Single dose (SD) in treatment B and C.
Experimental: Optional Scheme 4-5; Participants will receive nurandociguat new tablet for 7 days at a lower starting dose. Afterwards, there will be up titration to a higher dose for 11 days (nurandociguat old tablet for 5 days followed by PK analysis of old tablet formulation without food at steady state after 5 days; nurandociguat new tablet for 6 days followed by PK analysis of new tablet formulation without food at steady state after 5 days and with food after 6 days).	Drug: Nurandociguat (BAY3283142) old tablet; High dose once daily for 5 days.; Drug: Nurandociguat (BAY3283142) new tablet; Low dose once daily for 7 days, high dose once daily for 6 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optional scheme 1-3 - Cmax for nurandociguat	Cmax=Maximum observed concentration	0-72 hours post dose
Optional scheme 1-3 - AUC for nurandociguat	AUC=Area under the concentration time curve	0-72 hours post dose
Optional scheme 4 and 5 - Cmax,md for nurandociguat	Cmax,md=Cmax after multiple dosing	0-24 hours post dose
Optional scheme 4 and 5 - AUCt,md for nurandociguat	AUCt,md=AUC after multiple dosing. t (Tau)=24 hours.	0-24 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)	From the first dose of study intervention up to 7 days after end of treatment with study intervention

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): November 4, 2026

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 17, 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
• Other Study ID Numbers: 22700; 2025-524176-36-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

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

IPD Plan Description

Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access.

As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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.

Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies 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