Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101784
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-08-07
Brief Title:
Single and Multiple Ascending Oral Doses of Avenanthramide
Sponsor:
Montreal Heart Institute
Organization:
Montreal Heart Institute
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AvenActive
Brief 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 ie pro-inflammatory cytokines chemokines as well as other inflammatory markers ie 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
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 ie pro-inflammatory cytokines chemokines as well as other inflammatory markers ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None