2-HOBA: Initial Evaluation in Humans

NCT03176940 | Completed DMC

• 2 other identifiers: 161861R44AG055184
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Escalating Dosage

Outcome Measures

Primary Outcomes (1)

• Dose Tolerability

  Tolerability will be assessed by occurrence of Adverse Events (AEs). If AEs occur in 2 out of 6 volunteers, the dose will be declared not tolerated and the previous dose with no AEs will be declared maximum tolerable dose. AEs \< 2: dose is tolerated AEs ≥ 2: dose is not tolerated

  24 hours

Study Arms (6)

2-HOBA first dose

EXPERIMENTAL

Dose escalation studies in humans: 50mg dose

Dietary Supplement: 2-HOBA

2-HOBA second dose

EXPERIMENTAL

Dose escalation studies in humans: 100mg dose

Dietary Supplement: 2-HOBA

2-HOBA third dose

EXPERIMENTAL

Dose escalation studies in humans: 200mg dose

Dietary Supplement: 2-HOBA

2-HOBA fourth dose

EXPERIMENTAL

Dose escalation studies in humans: 330mg dose

Dietary Supplement: 2-HOBA

2-HOBA fifth dose

EXPERIMENTAL

Dose escalation studies in humans: 550mg dose

Dietary Supplement: 2-HOBA

2-HOBA sixth dose

EXPERIMENTAL

Dose escalation studies in humans: 825mg 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-Hydroxylbenzylamine

2-HOBA fifth dose; 2-HOBA first dose; 2-HOBA fourth dose; 2-HOBA second dose; 2-HOBA sixth dose; 2-HOBA third dose

Eligibility Criteria

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

You may qualify if:

• Healthy individuals older than 18;
• Males and females who are not pregnant at the time of the study; and
• Not taking any medication 2 weeks prior to and during the study.

You may not qualify if:

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

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, Rathmacher JA, Fuller JC Jr, Daniels JS, Morrison RD, Akers WS, Abumrad NN, Amarnath V, Currey PM, Roberts LJ, Oates JA, Boutaud O. First-in-human study assessing safety, tolerability, and pharmacokinetics of 2-hydroxybenzylamine acetate, a selective dicarbonyl electrophile scavenger, in healthy volunteers. BMC Pharmacol Toxicol. 2019 Jan 5;20(1):1. doi: 10.1186/s40360-018-0281-7.

  PMID: 30611293 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: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The dietary supplement will be delivered to the Clinical Research Center by the Investigational Pharmacy at Vanderbilt University Medical Center. Staff nurses and participants will be blinded to the capsule dosage content.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Model Details: The 3+3 design will be employed for this trial. At least 3 volunteers will be studied at each dose level and evaluated for adverse effects. If 0 of 3 volunteers experiences adverse events (AE), the dose is escalated. If 1 of 3 volunteers experiences an AE, 3 additional volunteers are treated. If none of the additional volunteers develop an AE, the dose is escalated, otherwise escalation ceases. If 2 of 3 or 2 of 6 volunteers experience an AE, the maximum tolerated dose (MTD) has been exceeded.

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: June 6, 2017
• Study Start: August 2, 2017
• Primary Completion: March 31, 2018
• Study Completion: April 30, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)