Clinical trial NCT03555682: 2-HOBA: Multiple Dosing Study in Healthy Humans
Official title: 2-Hydroxybenzylamine: Multiple Dosing Study in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Multiple Dosage
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University
name: National Institute on Aging (NIA)
First posted: 2018-06-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned in a blinded fashion to 2-HOBA or placebo. A computer-generated randomization sequence with a block of size 3 will be used to assign participants at the ratio of 1:2 (placebo:2-HOBA) at each dose level of the treatment. All participants receiving the lower dose regimen will be completed before enrolling participants in the higher dose group.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test how well people tolerate a new dietary ingredient called 2-HOBA and how it is metabolized in the body. 2-HOBA is a compound that occurs naturally in buckwheat seeds. This dietary ingredient has been used in animal studies, and single doses have been tolerated well when given to a small group of healthy people. In this study we will test how well people tolerate taking 2-HOBA over 2 weeks and how it is metabolized by the body.

Detailed description: Consenting healthy volunteers between 18 and 59 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. Eighteen volunteers will be studied with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit equal numbers of males and females. The study will be conducted by the Vanderbilt Clinical Research Center (CRC).

Based upon single dose pharmacokinetics, two multiple dose regimens will be studied to determine the safety, accumulation kinetics, and pharmacodynamic effects of multiple daily doses administered over 2 weeks. A complete health history and physical examination will be conducted by a physician. An EKG, baseline blood and urine sample, and vital signs will be taken prior to supplement administration. A physician will oversee all clinical aspects of the study and will be responsible for all trial-related medical decisions. Additionally, DNA will be collected from the blood drawn and used to determine if there are any genetic differences in metabolism of 2-HOBA. Volunteers will be given 3 daily doses of either placebo or one of two levels of 2-HOBA to determine the safety, accumulation kinetics, and pharmacodynamic effects of the multiple dose administration over a 2 week period.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals between 18 and 59 years old;
* Men and women who are not pregnant at the time of study; and
* Not taking any medication 2 weeks prior to or during the study.

Exclusion Criteria:

* Inability to give informed consent;
* Diseases that could manifest symptoms or signs that would confound interpretation of the relationship between 2-HOBA action and potential adverse effects;
* Diseases that could manifest morbidity;
* Known cardiac disease, kidney disease, or hepatic dysfunction;
* Need to discontinue any drug that is administered as standard of care treatment; and
* Unwillingness or inability to use approved birth-control methods.

Primary outcomes:
measure: Multiple Dose Tolerability
timeFrame: 15 Days
Secondary outcomes:
measure: Measurement of oxidative protein adducts in platelets
timeFrame: 15 Days
measure: Blood Pressure
timeFrame: 15 Days
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Day 1 and Day 15
measure: Area Under the Curve (AUC)
timeFrame: Day 1 and Day 15
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Metabolic Technologies Inc.
name: John A Rathmacher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pitchford LM, Driver PM, Fuller JC Jr, Akers WS, Abumrad NN, Amarnath V, Milne GL, Chen SC, Ye F, Roberts LJ 2nd, Shoemaker MB, Oates JA, Rathmacher JA, Boutaud O. Safety, tolerability, and pharmacokinetics of repeated oral doses of 2-hydroxybenzylamine acetate in healthy volunteers: a double-blind, randomized, placebo-controlled clinical trial. BMC Pharmacol Toxicol. 2020 Jan 6;21(1):3. doi: 10.1186/s40360-020-0382-y.