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2-HOBA: Initial Evaluation in Humans (2-HOBA)

This study is currently recruiting participants.
Verified September 2017 by John Rathmacher, PhD, Metabolic Technologies Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176940
First Posted: June 6, 2017
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Vanderbilt University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
John Rathmacher, PhD, Metabolic Technologies Inc.
  Purpose
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.

Condition Intervention
Healthy Volunteers Dietary Supplement: 2-HOBA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
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.
Masking: Double (Participant, Care Provider)
Masking Description:
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.
Primary Purpose: Basic Science
Official Title: 2-Hydroxybenzylamine: Initial Evaluation in Humans

Further study details as provided by John Rathmacher, PhD, Metabolic Technologies Inc.:

Primary Outcome Measures:
  • Dose Tolerability [ Time Frame: 24 hours ]

    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



Estimated Enrollment: 28
Actual Study Start Date: August 2, 2017
Estimated Study Completion Date: February 28, 2020
Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2-HOBA first dose
Dose escalation studies in humans: 50mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxylbenzylamine
Experimental: 2-HOBA second dose
Dose escalation studies in humans: 100mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxylbenzylamine
Experimental: 2-HOBA third dose
Dose escalation studies in humans: 200mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxylbenzylamine
Experimental: 2-HOBA fourth dose
Dose escalation studies in humans: 330mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxylbenzylamine
Experimental: 2-HOBA fifth dose
Dose escalation studies in humans: 550mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxylbenzylamine
Experimental: 2-HOBA sixth dose
Dose escalation studies in humans: 825mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxylbenzylamine

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176940


Contacts
Contact: Patricia M Currey, RN 615-322-4721 patricia.m.macleod-welsh@Vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Patricia M Currey, RN    615-322-4721    patricia.m.macleod-welsh@Vanderbilt.Edu   
Sponsors and Collaborators
Metabolic Technologies Inc.
Vanderbilt University
National Institute on Aging (NIA)
Investigators
Principal Investigator: John A Rathmacher, PhD Metabolic Technologies Inc.
  More Information

Responsible Party: John Rathmacher, PhD, Director of Clinical Research, Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT03176940     History of Changes
Other Study ID Numbers: 161861
R44AG055184 ( U.S. NIH Grant/Contract )
First Submitted: April 20, 2017
First Posted: June 6, 2017
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Rathmacher, PhD, Metabolic Technologies Inc.:
Escalating Dosage