Brain Penetrance of 2-HOBA in Humans

NCT03554096 | Completed DMC

• 2 other identifiers: MTI2018-CS03R44AG055184
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm that 2-HOBA crosses the blood brain barrier and to compare blood and cerebrospinal fluid levels of 2-HOBA after a single oral dose.

Conditions

Healthy Adults

Keywords

Multiple Dosage

Outcome Measures

Primary Outcomes (1)

• Brain Penetrance

  Ratio of 2-HOBA concentration in the cerebrospinal fluid to plasma 2-HOBA concentration after oral administration (ng/mL)

  90 minutes

Study Arms (1)

2-HOBA

EXPERIMENTAL

2-Hydroxybenzylamine acetate: 550mg dose

Dietary Supplement: 2-HOBA

Interventions

2-HOBA DIETARY_SUPPLEMENT

2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate

Also known as: 2-Hydroxybenzylamine

2-HOBA

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals between 40 and 70 years old;
• Men and women who are not pregnant at the time of study; and
• Not taking any medication 24 hours prior to and during the study.

You may not qualify if:

• Inability to give informed consent;
• Current use of anticoagulant medications, such as warfarin (Coumadin), dabigatran (Pradaxa), or rivaroxaban (Xarelto), due to high risk of bleeding complications. Volunteers taking aspirin or clopidogrel (Plavix), will not be excluded, but will be asked to get clearance from their prescribing physician before stopping the drug 24 hours prior to the procedure;
• Need to discontinue any drug that is administered as standard of care treatment;
• Unwillingness or inability to use approved birth-control methods (pre-menopausal women); and
• History of lumbar surgery, fibromyalgia, current lower back pain, or scoliosis.

Sponsors & Collaborators

• Metabolic Technologies Inc.: lead
• Vanderbilt University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 31907026 DERIVED

MeSH Terms

Interventions

2-(aminomethyl)phenol

Study Officials

• John A Rathmacher, PhD

  Metabolic Technologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The dietary supplement will be delivered to the Clinical Research Center by the Investigational Pharmacy at Vanderbilt University Medical Center.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: May 23, 2018
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)