Brain Penetrance of 2-HOBA in Humans

Not Applicable

Completed

• Conditions: Healthy Adults
• Interventions: Dietary Supplement: 2-HOBA

• Registration Number: NCT03554096
• Lead Sponsor: Metabolic Technologies Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-05-23
• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Status Verified: 2019-02
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-08
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2-HOBA	2-HOBA	2-Hydroxybenzylamine acetate: 550mg dose

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States