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.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Number of participants with treatment-emergent adverse events per treatment group
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Only sponsor personnel will be kept unblinded to allow for rapid safety signal detection.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Arm
Participants receive placebo matching nurandociguat plus 0.4 mg nitroglycerin spray
干预措施: Placebo (Drug)
Nurandociguat Arm
Participants receive nurandociguat plus 0.4 mg nitroglycerin spray
干预措施: Nitroglycerin spray (Drug)
Nurandociguat Arm
Participants receive nurandociguat plus 0.4 mg nitroglycerin spray
干预措施: Nurandociguat (Drug)
Placebo Arm
Participants receive placebo matching nurandociguat plus 0.4 mg nitroglycerin spray
干预措施: Nitroglycerin spray (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events per treatment group
时间窗: 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.
次要结局
未报告次要终点