Effect of Sublingually Generated S-nitroso-N-acetylcysteine on Systemic Blood Pressure.
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.
Conditions:
🦠 Hypertension 🦠 Cardiovascular Diseases
🗓️ Study Start (Actual) 1 March 2024
🗓️ Primary Completion (Estimated) 30 September 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 14
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 21 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 March 2023
  • First Submitted that Met QC Criteria 23 March 2023
  • First Posted 4 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 March 2024
  • Last Update Posted 28 March 2024
  • Last Verified March 2024