Single and Multiple Ascending Oral Doses of Avenanthramide

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.

Timeline

Start

2023-12-09

Primary completion

2025-06-16

Completion

2025-06-16

Drugs

Indications

No indication recorded.