COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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.

Quick Facts

Study Start:2024-03-27
Study Completion:2025-10-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05798481

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.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy male and female subjects who are at least 21 years old and who consent to participate in the study.
  2. * Participants must be willing to have approximately 15 mL of blood drawn via venipuncture and undergo blood pressure measurement.
  1. * 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.
  2. * 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.

Contacts and Locations

Principal Investigator

Nagababu Enika, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Brant Wagener, MD, PhD
STUDY_DIRECTOR
University of Alabama at Birmingham

Study Locations (Sites)

Anesthesiology and Perioperative Medicine
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: 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

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

Study Start Date2024-03-27
Study Completion Date2025-10-05

Study Record Updates

Study Start Date2024-03-27
Study Completion Date2025-10-05

Terms related to this study

Keywords Provided by Researchers

  • Nitric oxide
  • Sodium nitrite
  • N-acetylcysteine
  • S-nitrosothiols
  • systemic blood pressure
  • Vasodilators
  • Hypertension

Additional Relevant MeSH Terms

  • Hypertension
  • Cardiovascular Diseases