Evidence map›Paper›PMID 31907026›Full record

Trial reportBMC pharmacology & toxicology2020

Safety, tolerability, and pharmacokinetics of repeated oral doses of 2-hydroxybenzylamine acetate in healthy volunteers: a double-blind, randomized, placebo-controlled clinical trial.

Lisa M Pitchford, Patricia M Driver, John C Fuller, Wendell S Akers, Naji N Abumrad, Venkataraman Amarnath, Ginger L Milne, Sheau-Chiann Chen, Fei Ye, L Jackson Roberts and 4 more

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pharmacology & toxicology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.1field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03554096 nacompletednot on this map

Brain Penetrance of 2-Hydroxybenzylamine in Humans

TypeinterventionalSponsorMetabolic Technologies Inc.Ran2018 to 2019Enrolled3ConditionsHealthy AdultsArms2-HOBA
NCT03555682 nacompletednot on this map

2-Hydroxybenzylamine: Multiple Dosing Study in Healthy Humans

TypeinterventionalSponsorMetabolic Technologies Inc.Ran2018 to 2019Enrolled18ConditionsHealthy VolunteersArms2-HOBA, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
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  8. The role of T cells in vascular aging, hypertension, and atherosclerosis.American journal of physiology. Heart and circulatory physiology · 2024
    Review
  9. Review
  10. Atrial cardiomyopathy revisited-evolution of a concept: a clinical consensus statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asian Pacific Heart Rhythm Society (APHRS), and the Latin American Heart Rhythm Society (LAHRS).Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
    Article
  11. Immune Mechanisms in Hypertension.Hypertension (Dallas, Tex. : 1979) · 2024
    Review
  12. Review
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  15. Review
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  18. Innate immunity and clinical hypertension.Journal of human hypertension · 2022
    Review
  19. Emerging Anti-Atherosclerotic Therapies.International journal of molecular sciences · 2021
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 1 country.

Lisa M PitchfordMTI BioTech, Inc., Ames, IA, 50010, USA. pitchford@mti-hmb.com.ORCID 0000-0002-6402-0823
Patricia M DriverDepartment of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
John C FullerMTI BioTech, Inc., Ames, IA, 50010, USA.
Wendell S AkersDepartment of Pharmaceutical Sciences, Lipscomb University College of Pharmacy, Nashville, TN, 37204, USA.
Naji N AbumradDepartment of Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
Venkataraman AmarnathDepartment of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
Ginger L MilneDepartment of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
Sheau-Chiann ChenDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
Fei YeDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
L Jackson RobertsDepartment of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
M Benjamin ShoemakerDepartment of Medicine, Division of Cardiology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
John A OatesDepartment of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.
John A RathmacherMTI BioTech, Inc., Ames, IA, 50010, USA.
Olivier BoutaudDepartment of Pharmacology, Division of Clinical Pharmacology, Vanderbilt University, Nashville, TN, 37232, USA.
Vanderbilt University Medical Center · USIowa State University · USVanderbilt University · USLipscomb University · USMetabolic Technologies (United States) · US

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
2-Hydroxybenzylamine for the prevention of Alzheimer's disease: Initial evaluation in humansR44AG055184 · NIA · MTI BIOTECH, INC. · PI RATHMACHER, JOHN A · 2016 to 2017
$1.5M
NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR002243NIA NIH HHS R44 AG055184
6 · The paper itself

Abstract

background2-Hydroxybenzylamine (2-HOBA) is a selective dicarbonyl electrophile scavenger being developed as a nutritional supplement to help protect against the development of conditions associated with dicarbonyl electrophile formation, such as the cognitive decline observed with Mild Cognitive Impairment or Alzheimer's disease.

methodsThis study evaluated the safety, tolerability, and pharmacokinetics of repeated oral doses of 2-HOBA acetate (500 or 750 mg) administered to healthy volunteers every eight hours for two weeks. The effects of 2-HOBA on cyclooxygenase function and cerebrospinal fluid penetrance of 2-HOBA were also investigated.

resultsRepeated oral administration of 2-HOBA was found to be safe and well-tolerated up to 750 mg TID for 15 days. 2-HOBA was absorbed within 2 h of administration, had a half-life of 2.10-3.27 h, and an accumulation ratio of 1.38-1.52. 2-HOBA did not interfere with cyclooxygenase function and was found to be present in cerebrospinal fluid 90 min after dosing.

conclusionsRepeated oral administration of 2-HOBA was found to be safe and well-tolerated. These results support continued development of 2-HOBA as a nutritional supplement.

trial registrationStudies are registered at ClinicalTrials.gov (NCT03555682 Registered 13 June 2018, NCT03554096 Registered 12 June 18).

Indexed as

Dietary SupplementsAdministration, OralAdultBenzylaminesDouble-Blind MethodFemaleHealthy VolunteersHumansMaleMiddle AgedYoung Adult2-(aminomethyl)phenolBenzylaminesHumansPharmacokineticsSafetySalicylamineγ-Ketoaldehydes

Identifiers

PMID31907026
PMCPMC6945443
OpenAlexW3000153194

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.