drugset / Trial / NCT05798481
Effect of Sublingually Generated S-nitroso-N-acetylcysteine on Systemic Blood Pressure.
NaSingle-groupOpen-labelPrevention
Summary
The purpose of the study is to increase the in vivo levels of nitric oxide by generating nitric oxide donor compound S-nitrosoacetylcysteine (SNOAC) using the mixture of sodium nitrite and N-acetylcysteine crystals in the sublingual space. The generated SNOAC rapidly diffuses into blood circulation thereby decrease the systemic blood pressure. This compound can be an alternative to organic nitrate NO donor drugs without developing tolerance in patients.
Timeline
- Start
- 2024-03-27
- Primary completion
- 2025-04-29
- Completion
- 2025-10-05
Publications
- Background Farah C, Michel LYM, Balligand JL. Nitric oxide signalling in cardiovascular health and disease. Nat Rev Cardiol. 2018 May;15(5):292-316. doi: 10.1038/nrcardio.2017.224. Epub 2018 Feb 1.
- Background Secker-Walker LM, Craig JM, Hawkins JM, Hoffbrand AV. Philadelphia positive acute lymphoblastic leukemia in adults: age distribution, BCR breakpoint and prognostic significance. Leukemia. 1991 Mar;5(3):196-9.
- Background Munzel T, Daiber A, Gori T. More answers to the still unresolved question of nitrate tolerance. Eur Heart J. 2013 Sep;34(34):2666-73. doi: 10.1093/eurheartj/eht249. Epub 2013 Jul 17.
- Background Al-Sa'doni H, Ferro A. S-Nitrosothiols: a class of nitric oxide-donor drugs. Clin Sci (Lond). 2000 May;98(5):507-20.
- Background Sun J, Murphy E. Protein S-nitrosylation and cardioprotection. Circ Res. 2010 Feb 5;106(2):285-96. doi: 10.1161/CIRCRESAHA.109.209452.
- Background Daiber A, Xia N, Steven S, Oelze M, Hanf A, Kroller-Schon S, Munzel T, Li H. New Therapeutic Implications of Endothelial Nitric Oxide Synthase (eNOS) Function/Dysfunction in Cardiovascular Disease. Int J Mol Sci. 2019 Jan 7;20(1):187. doi: 10.3390/ijms20010187.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Nitrite | Small molecule | 2.5 mg | Subcutaneous |
| Subject | Sodium Nitrite | Small molecule | 5 mg | Subcutaneous |
| Background | N-acetylcysteine | Small molecule | 50 mg | Subcutaneous |