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NCT05798481 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Early Phase 1
Development phase
14
Enrollment target

NCT05798481: Completed Early Phase 1 study, sponsored by University of Alabama at Birmingham.

NCT05798481 is a Early Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 14 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05798481, a Early Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Early Phase 1
Development phase
14 participants
Enrollment target

Study 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.

Primary Outcome

Plasma level of nitrite, nitrate and S-nitrosothiols species (nanomol/L) will be measured by highly validated ozone-based chemiluminescience assay before, during and the end of sublingual administration of S-nitrosoacetylcysteine in study participants The drug effect will be assessed based on the change in the nitrite, nitrate and S-nitrosothiol values from the baseline levels following the administration of the drug.

Interventions

  • DRUG Mixture of Sodium Nitrite and N-acetylcysteine (NAC) crytals.

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2024-03-27
Est. Completion 2025-10-05
Phase Early Phase 1
University of Alabama at Birmingham

1,160 total trials

What the finished NCT05798481 record still lists

NCT05798481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 1 intervention - of which Mixture of Sodium Nitrite and N-acetylcysteine (NAC) crytals. is the first listed.

NCT05798481 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05798481 about?

NCT05798481 is a clinical study titled "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 ...

What is the current status of trial NCT05798481?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2024-03-27. Estimated completion is 2025-10-05.

What interventions are being tested in trial NCT05798481?

The interventions under investigation include: Mixture of Sodium Nitrite and N-acetylcysteine (NAC) crytals. (DRUG).

Who is sponsoring clinical trial NCT05798481?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05798481's enrollment target sits among peer trials

14 1475th of 2000 higher than 498 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05798481, the US trial registry maintained by the National Library of Medicine. NCT05798481 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.