Brain Penetrance of 2-Hydroxybenzylamine in Humans

Brain Penetrance of 2-HOBA in Humans



Sponsors


Source

Metabolic Technologies Inc.

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2018-05-23

Completion Date

2019-02-28

Primary Completion Date

2018-10-28

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Brain Penetrance
90 minutes

Enrollment

3

Condition


Intervention

Intervention Type

Dietary Supplement

Intervention Name


Description

2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate

Arm Group Label

2-HOBA

Other Name

2-Hydroxybenzylamine


Eligibility

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.

Gender

All

Minimum Age

40 Years

Maximum Age

70 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

John A Rathmacher, PhD
Principal Investigator
Metabolic Technologies Inc.

Overall Contact

Last Name

Patricia M Currey, RN

Phone

615-322-4721

Email



Location

Facility

Status

Contact

Vanderbilt University Medical Center
Nashville Tennessee 37232 United States
Recruiting
Last Name: Patricia M Currey, RN
Phone: 615-322-4721
Email: [email protected]

Location Countries

Country

United States


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Metabolic Technologies Inc.

Investigator Full Name

John Rathmacher, PhD

Investigator Title

Director of Clinical Research


Keyword


Has Expanded Access

No

Secondary Id

R44AG055184

Number Of Arms

1

Arm Group

Arm Group Label

2-HOBA

Arm Group Type

Experimental

Description

2-Hydroxybenzylamine acetate: 550mg dose


Firstreceived Results Date

N/A

Acronym

2-HOBA

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Basic Science

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.


Study First Submitted

May 29, 2018

Study First Submitted Qc

June 11, 2018

Study First Posted

June 12, 2018

Last Update Submitted

June 11, 2018

Last Update Submitted Qc

June 11, 2018

Last Update Posted

June 12, 2018


ClinicalTrials.gov processed this data on August 28, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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