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2-HOBA: Initial Evaluation in Humans

NCT03176940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

2-HOBA

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

Sponsors & Collaborators

  • Vanderbilt University

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Metabolic Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • John A Rathmacher, PhD · Metabolic Technologies Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2018-03-31
Completion
2018-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176940 on ClinicalTrials.gov