Using a new method to lower blood pressure with a nitric oxide donor
A Pilot Pre-Phase 1 Clinical Trial to Study How Administering Sublingual Nitric Oxide Donor S-nitroso-N-acetylcysteine Affects the Systemic Blood Pressure in Healthy Human Volunteers.
This study is testing a new way to lower blood pressure using a special compound made from common ingredients to see if it works better and is safer than traditional medications.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05798481 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance nitric oxide levels in the body by generating a compound called S-nitrosoacetylcysteine (SNOAC) through a mixture of sodium nitrite and N-acetylcysteine in the sublingual space. The generated SNOAC is designed to quickly enter the bloodstream and lower systemic blood pressure. This approach seeks to provide an alternative to traditional organic nitrate drugs, which often lead to tolerance in patients. The study will confirm preclinical findings regarding the effectiveness and safety of this method in healthy participants.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 21 and older who can provide informed consent.
Not a fit: Patients with major cardiovascular issues, those taking organic nitrates or sildenafil, and individuals under 21 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a new, effective treatment for managing hypertension without the tolerance issues associated with existing nitrate therapies.
How similar studies have performed: While the approach of using S-nitrosothiols is established, this specific method of generating SNOAC sublingually is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy male and female subjects who are at least 21 years old and who consent to participate in the study. * Participants must be willing to have approximately 15 mL of blood drawn via venipuncture and undergo blood pressure measurement. Exclusion Criteria: * Individuals who are below 21 years of age, pregnant, have major cardiovascular problems or sickle cell disease, incarcerated individuals or are unable to give consent will be excluded. * Those whose blood pressure is below normal (i.e., 120/80) and those who have cardiovascular problems and taking organic nitrates and sildenafil-based drugs will also be excluded.
Where this trial is running
Birmingham, Alabama
- Anesthesiology and Perioperative Medicine — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Nagababu Enika, PhD — University of Alabama at Birmingham
- Study coordinator: Raneisha Lee, M.S.
- Email: raneisha@uab.edu
- Phone: (205) 432-8656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.