Effect of Sublingually Generated S-nitroso-N-acetylcysteine on Systemic Blood Pressure.

Description

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

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Study Overview

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Study Details

Study overview

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.

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.

Effect of Sublingually Generated S-nitroso-N-acetylcysteine on Systemic Blood Pressure.

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Birmingham

Anesthesiology and Perioperative Medicine, Birmingham, Alabama, United States, 35294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Alabama at Birmingham,

Nagababu Enika, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Brant Wagener, MD, PhD, STUDY_DIRECTOR, University of Alabama at Birmingham

Study Record Dates

2025-12-31