Chronic Kidney DiseasePhase 1NCT07515339
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
A Phase 1 study testing Nurandociguat, Rosuvastatin and Dabigatran etexilate in people with Chronic Kidney Disease, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Nurandociguat, Rosuvastatin and Dabigatran etexilate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2026to 26 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Services | Clinical Research Services Mannheim - Phase one unit
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: 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.
Read more
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Nurandociguat, Rosuvastatin, Dabigatran etexilate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NurandociguatDrug
Low dose once daily for 7 days, higher single dose
RosuvastatinDrug
Single dose (SD)
Dabigatran etexilateDrug
Single Dose (SD)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (rosuvastatin, nurandociguat + rosuvastatin) | Experimental | 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. Receives: Drug: Nurandociguat; Drug: Rosuvastatin |
| Arm 2 (dabigatran etexilate, nurandociguat + dabigatran etexilate) | Experimental | 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. Receives: Drug: Nurandociguat; Drug: Dabigatran etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of rosuvastatin
Measured: 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
Measured: 0-48 hours after administration of rosuvastatin in Day 1 of each treatment period
Cmax of unconjugated dabigatran
Measured: 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
Measured: 0-48 hours after administration of dabigatran etexilate in Day 1 of each treatment period
Secondary outcomes (1)
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: From the start of study intervention up to 7 days after the last study intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start8 Apr 2026 (estimated)
- Primary completion26 Jun 2026 (estimated)
- Study completion26 Jun 2026 (estimated)
Why it stopped: The study is no longer required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515339
- Sponsor's protocol ID
- 22600
- Status last verified
- May 2026
- First submitted
- 19 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Investigate the Influence of Nurandociguat on the Pharmacokinetics of Rosuvastatin and Dabigatran in Healthy Participants
- ClinicalTrials.gov ID
- NCT07515339
- Acronym / sponsor ID
- 22600
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is no longer required.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2026 (estimated)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 26 Jun 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (rosuvastatin, nurandociguat + rosuvastatin) | Experimental | Drug: Nurandociguat, Drug: RosuvastatinParticipants 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. |
| Arm 2 (dabigatran etexilate, nurandociguat + dabigatran etexilate) | Experimental | Drug: Nurandociguat, Drug: Dabigatran etexilateParticipants 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. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NurandociguatLow dose once daily for 7 days, higher single dose | Drug | Arm 1 (rosuvastatin, nurandociguat + rosuvastatin), Arm 2 (dabigatran etexilate, nurandociguat + dabigatran etexilate) |
| RosuvastatinSingle dose (SD) | Drug | Arm 1 (rosuvastatin, nurandociguat + rosuvastatin) |
| Dabigatran etexilateSingle Dose (SD) | Drug | Arm 2 (dabigatran etexilate, nurandociguat + dabigatran etexilate) |
Primary outcome
Cmax of rosuvastatin
Time frame: 0-48 hours after administration of rosuvastatin in Day 1 of each treatment period
AUC of rosuvastatin
Time frame: 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
Time frame: 0-48 hours after administration of dabigatran etexilate in Day 1 of each treatment period
AUC of unconjugated dabigatran
Time frame: 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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nurandociguat, Rosuvastatin and Dabigatran etexilate in people with Chronic Kidney Disease, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of rosuvastatin (time frame: 0-48 hours after administration of rosuvastatin in Day 1 of each treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.