Brain Penetrance of 2-HOBA in Humans | NCT03554096

Studies
Brain Penetrance of 2-HOBA in Humans

NCT03554096

Sponsor

Metabolic Technologies Inc.

Status

Completed

Last Update Posted

Feb 20, 2019Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Healthy Adults

Interventions

2-HOBA

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R44AG055184	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2018Actual

Primary Completion Date

Feb 8, 2019Actual

Completion Date

Feb 8, 2019Actual

First Submitted Date

May 29, 2018

First Submission Date that Met QC Criteria

Jun 11, 2018

First Posted Date

Jun 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2019

Last Update Posted Date

Feb 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Rathmacher, PhD, Director of Clinical Research, Metabolic Technologies Inc.Principal Investigator

Lead Sponsor

Metabolic Technologies Inc.INDUSTRY

Collaborators

Name	Class
Vanderbilt University	OTHER
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2-HOBA	Experimental	2-Hydroxybenzylamine acetate: 550mg dose	Dietary Supplement: 2-HOBA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2-HOBA	Dietary Supplement	2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate	2-HOBA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John A Rathmacher, PhD	Metabolic Technologies Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31907026	Derived	Pitchford LM, Driver PM, Fuller JC Jr, Akers WS, Abumrad NN, Amarnath V, Milne GL, Chen SC, Ye F, Roberts LJ 2nd, Shoemaker MB, Oates JA, Rathmacher JA, Boutaud O. Safety, tolerability, and pharmacokinetics of repeated oral doses of 2-hydroxybenzylamine acetate in healthy volunteers: a double-blind, randomized, placebo-controlled clinical trial. BMC Pharmacol Toxicol. 2020 Jan 6;21(1):3. doi: 10.1186/s40360-020-0382-y.