2-HOBA: Initial Evaluation in Humans

Metabolic Technologies

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: 2-HOBA

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03176940

R44AG055184 (U.S. NIH Grant/Contract)

161861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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18 participants in 6 patient groups

2-HOBA first dose

Experimental group

Description:

Dose escalation studies in humans: 50mg dose

Treatment:

Dietary Supplement: 2-HOBA

2-HOBA second dose

Experimental group

Description:

Dose escalation studies in humans: 100mg dose

Treatment:

Dietary Supplement: 2-HOBA

2-HOBA third dose

Experimental group

Description:

Dose escalation studies in humans: 200mg dose

Treatment:

Dietary Supplement: 2-HOBA

2-HOBA fourth dose

Experimental group

Description:

Dose escalation studies in humans: 330mg dose

Treatment:

Dietary Supplement: 2-HOBA

2-HOBA fifth dose

Experimental group

Description:

Dose escalation studies in humans: 550mg dose

Treatment:

Dietary Supplement: 2-HOBA

2-HOBA sixth dose

Experimental group

Description:

Dose escalation studies in humans: 825mg dose

Treatment:

Dietary Supplement: 2-HOBA