A Study to Learn About How Safe Nitroglycerin is and How it Affects the Body When Taken Along With Nurandociguat in People With Coronary Artery Disease

NCT07431294 | Not Yet Recruiting Phase 1

• 2 other identifiers: 225972025-522335-34-00
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 5

Brief Summary

This study is designed to find out how safe nitroglycerin is and how it affects the body when it is taken together with another medicine called nurandociguat in people who have coronary artery disease (CAD). CAD is a condition where the arteries that supply blood to the heart become narrowed or blocked, often causing chest pain or even heart attacks. Many people with CAD also have chronic kidney disease (CKD), a long-term condition where the kidneys do not work as well as they should. People with CAD often use nitroglycerin to help improve blood flow to the heart. Nurandociguat is a new medicine being studied to help people with CKD by widening blood vessels and improving blood flow. Both nitroglycerin and nurandociguat work in similar ways in the body, so taking them together could have a stronger effect on blood vessels. This might lead to a sudden drop in blood pressure or other side effects. The main goal of this study is to learn how safe it is to use nitroglycerin and nurandociguat together, and to understand how they interact in the body.

Conditions

Stable Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events per treatment group

  The incidence of treatment-emergent adverse events will be summarized.

  Up to 7 days after the last treatment, for a total of up to about 7 weeks per participant

Study Arms (2)

Nurandociguat Arm

EXPERIMENTAL

Participants receive nurandociguat plus 0.4 mg nitroglycerin spray

Drug: Nitroglycerin spray; Drug: Nurandociguat

Placebo Arm

PLACEBO COMPARATOR

Participants receive placebo matching nurandociguat plus 0.4 mg nitroglycerin spray

Drug: Nitroglycerin spray; Drug: Placebo

Interventions

Nitroglycerin spray DRUG

0.4 mg sublingual spray

Nurandociguat Arm; Placebo Arm

Nurandociguat DRUG

Tablet, oral

Nurandociguat Arm

Placebo DRUG

Tablet matching nurandociguat, oral

Placebo Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 40 to 80 years of age inclusive at the time of signing the informed consent
• Participants with stable CAD defined by coronary artery stenosis in any of the 3 main coronary vessels greater than 50 percent documented by coronary angiography within the last 36 months or history of myocardial infarction more than 6 months prior to the screening visit
• Estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL per min per 1.73 m2 at screening
• Body weight greater than or equal to 60 kg and body mass index within the range greater than or equal to 18 and less than or equal to 36 kg per m2 at screening.

You may not qualify if:

• Ejection fraction less than 30 percent at screening as determined by echocardiography
• Progressive angina with symptoms of worsening of angina in the 3 months prior to the first screening examination and/or interventions such as revascularization by percutaneous coronary intervention and or coronary artery bypass graft during the last 3 months
• Documented current relevant coronary stenosis greater than or equal to 90 percent in any of the main 3 coronary vessels without bypass graft
• Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis any other moderate or severe valvular failures hypertrophic obstructive cardiomyopathy
• Symptomatic carotid stenosis or transient ischemic attack or stroke within 3 months prior to the first screening examination or patients with stroke at more than 3 months prior to the first screening examination with significant residual neurologic involvement
• Atrial fibrillation pacemaker defibrillator atrial ventricular block II and III
• History of sustained ventricular tachycardia or ventricular fibrillation within 12 months prior first screening visit
• History of CNS diseases such as seizures neurodegenerative diseases
• Lung diseases such as COPD GOLD stage 2-4 pulmonary arterial hypertension or asthma
• Medical disorder condition or history of such that would impair the participant's ability to participate or complete the study in the opinion of the investigator.

Sponsors & Collaborators

• Bayer: lead

Study Sites (5)

Comac Medical | Phase I Clinical Research Unit

Sofia, Sofia City Province, 1000, Bulgaria

Location

Deutsches Herzzentrum der Charité (DHZC) - Klinik für Kardiologie, Angiologie und Intensivmedizin CVK

Berlin, 13353, Germany

Location

UK Bonn Institut für Klinische Chemie und Klinische Pharmakologie, Phase I Einheit und Arzneimitteltherapiesicherheit

Bonn, 53127, Germany

Location

SocraTec R&D Erfurt-Clinical Pharmacology Unit

Erfurt, 99084, Germany

Location

Universitätsklinikum Heidelberg - Zentrum für Innere Medizin, Abteilung Klinische Pharmakologie und Pharmakoepidemologie

Heidelberg, 69120, Germany

Location

Central Study Contacts

Therapeutic Area Head

CONTACT

4930300139003; clinical-trials-contact@bayer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only sponsor personnel will be kept unblinded to allow for rapid safety signal detection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 7, 2027
• Study Completion (Estimated): May 7, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); BU (1)