Brain Penetrance of 2-HOBA in Humans

Healthy Adults Clinical Trial

— 2-HOBA  

Official title:

Brain Penetrance of 2-Hydroxybenzylamine in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554096
• Other study ID #: MTI2018-CS03
• Secondary ID: R44AG055184
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: February 8, 2019

Study information

• Verified date: February 2019
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to confirm that 2-HOBA crosses the blood brain barrier and to compare blood and cerebrospinal fluid levels of 2-HOBA after a single oral dose.

Description:

Consenting volunteers between 40 and 70 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. Three volunteers will be enrolled with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit males and females. The study will be conducted by the Vanderbilt Clinical Research Center (CRC).

Briefly, the three volunteers will be studied at a single dose level. Baseline assessments will be performed, and then each volunteer will be given a single oral dose (550 mg) of 2-HOBA. Ninety minutes after the dose, a lumbar puncture will be performed to obtain cerebrospinal fluid and a blood sample will be collected. 2-HOBA levels will be measured in cerebrospinal fluid and blood samples from this timepoint to assess the ability or orally ingested 2-HOBA to cross the blood brain barrier.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy individuals between 40 and 70 years old;

• Men and women who are not pregnant at the time of study; and

• Not taking any medication 24 hours prior to and during the study.

Exclusion Criteria:

• Inability to give informed consent;

• Current use of anticoagulant medications, such as warfarin (Coumadin), dabigatran (Pradaxa), or rivaroxaban (Xarelto), due to high risk of bleeding complications. Volunteers taking aspirin or clopidogrel (Plavix), will not be excluded, but will be asked to get clearance from their prescribing physician before stopping the drug 24 hours prior to the procedure;

• Need to discontinue any drug that is administered as standard of care treatment;

• Unwillingness or inability to use approved birth-control methods (pre-menopausal women); and

• History of lumbar surgery, fibromyalgia, current lower back pain, or scoliosis.

Related Conditions & MeSH terms

• Healthy Adults

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	Brain Penetrance	Ratio of 2-HOBA concentration in the cerebrospinal fluid to plasma 2-HOBA concentration after oral administration (ng/mL)	90 minutes