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Single and Multiple Ascending Oral Doses of Avenanthramide — AvenActive  

Inflammation Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled, Randomized, Adaptive, First-in-Human Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Avenanthramide

Clinical Trial Summary

Avenanthramides (AVA) are di-phenolic compounds found only in oats and are of interest due to suggested bioactivities, including antioxidant and anti-inflammatory effects in vitro and in vivo. Published data suggests that polyphenols can work as modifiers of signal transduction pathways to elicit their beneficial effects. These natural compounds express anti-inflammatory activity by modulation of pro-inflammatory gene expression such as cyclo-oxygenase, lipoxygenase, nitric oxide synthases and several pivotal cytokines, mainly by acting through nuclear factor-kappa B and mitogen-activated protein kinase signaling. The biomarkers of inflammation in blood, i.e., pro-inflammatory cytokines, chemokines, as well as other inflammatory markers (i.e., high sensitivity C-reactive protein) are of particular interest. Primary Objectives: - To assess the safety and tolerability of single ascending oral doses of avenanthramide in healthy subjects. - To assess the safety and tolerability of multiple ascending oral doses of avenanthramide in healthy subjects and subjects with elevated waist circumference and low-grade inflammation. Secondary Objectives: - To determine the pharmacokinetics of avenanthramide following single ascending oral doses in healthy subjects. - To compare the pharmacokinetics of avenanthramide following single oral dose in healthy subjects under fasting and fed conditions. - To determine the pharmacokinetics of avenanthramide following multiple ascending oral doses in healthy subjects. - To determine the pharmacokinetics of avenanthramide following multiple ascending oral doses in subjects with elevated waist circumference and low-grade inflammation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06101784
Study type Interventional
Source Montreal Heart Institute
Contact Jean-Claude Tardif, MD
Phone 514-376-3330
Email jean-claude.tardif@icm-mhi.org
Status Recruiting
Phase Phase 1/Phase 2
Start date December 9, 2023
Completion date September 2025
View Details
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