NCT01681836

Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

An Open-Label Study of Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Gladwin, Mark, MD · Individual
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and nitrite capsules for cardiovascular disease.

Detailed description

Preclinical and clinical research over the last decade has revealed the important vasoprotective effects of nitrates and nitrites with regards to reduction in blood pressure, vascular inflammation and endothelial dysfunction. New findings suggest an effect of nitrate and nitrite therapy in the regulation of glucose-insulin homeostasis. Development of an oral formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the nitrate would continuously provide a slow formation of nitrite over a prolonged period of time via the enterosalivary circulation pathway. For this reason, development of an oral formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the nitrate would continuously provide a slow formation of nitrite over a prolonged period of time via the enterosalivary circulation pathway. This study aims to establish the pharmacokinetics, metabolism and interconversion of nitrate to nitrite and nitrite to nitric oxide in vivo in healthy adult normal volunteers.

Conditions

• Focus of Study of Healthy Adults

Interventions

Type	Name	Description
DRUG	15Nitrogen(15N)-labeled sodium nitrite	15Nitrogen(15N)-labeled sodium nitrite 20 mg once
DRUG	15Nitrogen(15N)-labeled sodium nitrate	15Nitrogen(15N)-labeled sodium nitrate 1,000 mg once

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-09-10
• Last updated: 2018-09-04
• Results posted: 2018-09-04

Locations

1 site across 1 country: United States