Healthy Volunteers Clinical Trial
Official title:
2-Hydroxybenzylamine: Initial Evaluation in Humans
The purpose of this study is to evaluate the administration of single doses of 2-HOBA in humans, with an escalation of doses that begins with the calculated Maximum Recommended Starting Dose. This evaluation will assess tolerability to oral administration of 2-HOBA, obtain pharmacokinetic data, characterize the 2-HOBA metabolic pathways, and determine the relation of dose to prevention of formation of bi-functional electrophile adducts in blood. Characterization of the metabolic fate of 2-HOBA will be supported by investigations that evaluate metabolism in microsomes and cells.
Consenting volunteers of at least 18 years old with no morbidity, including males, and
females who are not pregnant will be recruited for the study. A maximum of 28 volunteers may
be enrolled with a reasonable sampling of ethnicities from the Nashville area, and an effort
will be made to recruit equal numbers of males and females. Additionally, an effort will be
made to study as old a population as possible and to recruit relatively similar age groups
for males and females. All volunteers will be admitted to the Vanderbilt Clinical Research
Center (CRC) as inpatients.
A complete health history and physical examination will be conducted by a physician.
Volunteers will be asked to collect and bring their first morning voided urine for baseline
urinalysis. An EKG, baseline blood analysis, vital signs, and questions about feelings and
adverse events will be asked prior to supplement administration. All tests will be repeated
at various intervals throughout the 24-hour study period. A physician will oversee all
clinical aspects of the study and will be responsible for all trial-related medical
decisions. Pharmacokinetics will be studied through the blood analyses at intervals
throughout the study and 24-hour urine collection after administration of the supplement.
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