CompletedPhase 1/2

Single and Multiple Ascending Oral Doses of Avenanthramide

Canada92 participantsStarted 2023-12-09

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is able to procreate and agrees to use one of the accepted contraceptive regimens and not donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:
✓. Subject is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 6 months prior to the first study drug administration)
✓. Subject of childbearing potential must agree to use an effective double method of birth control from the first study drug administration to at least 30 days after the last drug administration: barrier method (e.g., male or female condoms, spermicides, sponges, foams, jellies, and diaphragm) in combination with other methods of contraception including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices; or must have a sterile sexual partner.
✓. Subject is of childbearing potential and agrees to abide by true abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject (not periodic abstinence) Or
✓. Subject is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a menopausal state (i.e., at least 1 year without menses prior to the first study drug administration).

What they're measuring

Incidence of Adverse Events (Safety and Tolerability)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Trial details

NCT IDNCT06101784

SponsorMontreal Heart Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-16

View on ClinicalTrials.gov More Inflammation trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is able to procreate and agrees to use one of the accepted contraceptive regimens and not donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:
✓. Subject is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 6 months prior to the first study drug administration)
✓. Subject of childbearing potential must agree to use an effective double method of birth control from the first study drug administration to at least 30 days after the last drug administration: barrier method (e.g., male or female condoms, spermicides, sponges, foams, jellies, and diaphragm) in combination with other methods of contraception including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices; or must have a sterile sexual partner.
✓. Subject is of childbearing potential and agrees to abide by true abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject (not periodic abstinence) Or
✓. Subject is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a menopausal state (i.e., at least 1 year without menses prior to the first study drug administration).

What they're measuring

Incidence of Adverse Events (Safety and Tolerability)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose

Change in laboratory parameters (general biochemistry)

Timeframe: from drug administration up to 24 hours after the last dose