2-HOBA: Initial Evaluation in Humans

Healthy Volunteers Clinical Trial

— 2-HOBA  

Official title:

2-Hydroxybenzylamine: Initial Evaluation in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176940
• Other study ID #: 161861
• Secondary ID: R44AG055184
• Status: Completed
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2018
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 30, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.	National Institute on Aging (NIA), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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