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Brain Penetrance of 2-HOBA in Humans (2-HOBA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554096
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
Vanderbilt University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
John Rathmacher, PhD, 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.

Condition or disease Intervention/treatment Phase
Healthy Adults Dietary Supplement: 2-HOBA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The dietary supplement will be delivered to the Clinical Research Center by the Investigational Pharmacy at Vanderbilt University Medical Center.
Primary Purpose: Basic Science
Official Title: Brain Penetrance of 2-Hydroxybenzylamine in Humans
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : February 8, 2019

Arm Intervention/treatment
Experimental: 2-HOBA
2-Hydroxybenzylamine acetate: 550mg dose
Dietary Supplement: 2-HOBA
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other Name: 2-Hydroxybenzylamine




Primary Outcome Measures :
  1. Brain Penetrance [ Time Frame: 90 minutes ]
    Ratio of 2-HOBA concentration in the cerebrospinal fluid to plasma 2-HOBA concentration after oral administration (ng/mL)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03554096


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Metabolic Technologies Inc.
Vanderbilt University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: John A Rathmacher, PhD Metabolic Technologies Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Rathmacher, PhD, Director of Clinical Research, Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT03554096    
Other Study ID Numbers: MTI2018-CS03
R44AG055184 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
Multiple Dosage