Healthy Adults2-HOBANCT03554096
Brain Penetrance of 2-HOBA in Humans
A study testing 2-HOBA in people with Healthy Adults, run by Metabolic Technologies Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- 2-HOBA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2018to 8 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Brain Penetrance of 2-Hydroxybenzylamine in Humans
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.
Read the 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.
- Conditions
- Healthy Adults
- Being tested
- 2-HOBA
- Keywords
- Multiple Dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-HOBADietary supplement
Also called 2-Hydroxybenzylamine
2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
| Study group | Role | What they receive |
|---|---|---|
| 2-HOBA | Experimental | 2-Hydroxybenzylamine acetate: 550mg dose Receives: Dietary Supplement: 2-HOBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Penetrance
Ratio of 2-HOBA concentration in the cerebrospinal fluid to plasma 2-HOBA concentration after oral administration (ng/mL)
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start23 May 2018
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, John Rathmacher, PhD, Metabolic Technologies Inc.
- Investigators
- John A Rathmacher, PhD, Principal investigator, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554096
- Sponsor's protocol ID
- MTI2018-CS03
- Other IDs
- R44AG055184
- Acronym
- 2-HOBA
- Status last verified
- Feb 2019
- First submitted
- 29 May 2018
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31907026
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Penetrance of 2-Hydroxybenzylamine in Humans
- ClinicalTrials.gov ID
- NCT03554096
- Acronym / sponsor ID
- 2-HOBA / MTI2018-CS03
- Conditions
- Healthy Adults
- Keywords
- Multiple Dosage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University, National Institute on Aging (NIA)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2-HOBA | Experimental | Dietary Supplement: 2-HOBA2-Hydroxybenzylamine acetate: 550mg dose |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-HOBAAlso: 2-Hydroxybenzylamine2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate | Dietary supplement | 2-HOBA |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 31907026Pitchford 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Rathmacher, PhD principal investigator
Metabolic Technologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-HOBA in people with Healthy Adults, run by Metabolic Technologies Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Penetrance (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.