2-HOBA: Initial Evaluation in Humans

NCT ID: NCT03176940

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-02
• Study Completion Date: 2018-04-30

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.

Detailed Description

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

2-HOBA first dose

Dose escalation studies in humans: 50mg dose

Group Type: EXPERIMENTAL

2-HOBA

Intervention Type: DIETARY_SUPPLEMENT

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

2-HOBA second dose

Dose escalation studies in humans: 100mg dose

Group Type: EXPERIMENTAL

2-HOBA

Intervention Type: DIETARY_SUPPLEMENT

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

2-HOBA third dose

Dose escalation studies in humans: 200mg dose

Group Type: EXPERIMENTAL

2-HOBA

Intervention Type: DIETARY_SUPPLEMENT

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

2-HOBA fourth dose

Dose escalation studies in humans: 330mg dose

Group Type: EXPERIMENTAL

2-HOBA

Intervention Type: DIETARY_SUPPLEMENT

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

2-HOBA fifth dose

Dose escalation studies in humans: 550mg dose

Group Type: EXPERIMENTAL

2-HOBA

Intervention Type: DIETARY_SUPPLEMENT

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

2-HOBA sixth dose

Dose escalation studies in humans: 825mg dose

Group Type: EXPERIMENTAL

2-HOBA

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

2-HOBA

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

2-Hydroxylbenzylamine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Metabolic Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

John Rathmacher, PhD

Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John A Rathmacher, PhD

Role: PRINCIPAL_INVESTIGATOR

Metabolic Technologies Inc.

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30611293 (View on PubMed)

Other Identifiers

R44AG055184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

161861

Identifier Type: -

Identifier Source: org_study_id