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NCT Number: NCT07431294

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comac Medical | Phase I Clinical Research Unit, Sofia, Sofia City Province, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Nitroglycerin spray

Drug

0.4 mg sublingual spray

Nurandociguat

Drug

Tablet, oral

Placebo

Drug

Tablet matching nurandociguat, oral

Primary outcomes

  1. Number of participants with treatment-emergent adverse events per treatment group

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Therapeutic Area Head

CONTACT

[email protected]

4930300139003

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Placebo-controlled, Single Blind Drug-drug Interaction Study to Investigate the Influence of 0.4 mg Nitroglycerin Spray on the Safety, Tolerability and Pharmacodynamic Effects of Nurandociguat in Participants With Stable Coronary Artery Disease.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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