First-in-human study assessing safety, tolerability, and pharmacokinetics of 2-hydroxybenzylamine acetate, a selective dicarbonyl electrophile scavenger, in healthy volunteers View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-12

AUTHORS

Lisa M. Pitchford, John A. Rathmacher, John C. Fuller, J. Scott Daniels, Ryan D. Morrison, Wendall S. Akers, Naji N. Abumrad, Venkataraman Amarnath, Patricia M. Currey, L. Jackson Roberts, John A. Oates, Olivier Boutaud

ABSTRACT

2-Hydroxybenzylamine (2-HOBA) is a selective scavenger of dicarbonyl electrophiles that protects proteins and lipids from being modified by these electrophiles. It is currently being developed for use as a nutritional supplement to help maintain good health and protect against the development of conditions associated with dicarbonyl electrophile formation, such as the cognitive decline associated with Mild Cognitive Impairment and Alzheimer’s disease. In this first-in-human study, the safety, tolerability, and pharmacokinetics of six ascending single oral doses of 2-HOBA acetate were tested in eighteen healthy human volunteers. Reported adverse events were mild and considered unlikely to be related to 2-HOBA. There were no clinically significant changes in vital signs, ECG recordings, or clinical laboratory parameters. 2-HOBA was fairly rapidly absorbed, with a tmax of 1–2 h, and eliminated, with a t1/2 of approximately 2 h. Both tmax and t1/2 were independent of dose level, while Cmax and AUC increased proportionally with dose level. 2-HOBA acetate was safe and well-tolerated at doses up to 825 mg in healthy human volunteers, positioning it as a good candidate for continued development as a nutritional supplement. This study is registered at ClinicalTrials.gov (NCT03176940). More... »

PAGES

1

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s40360-018-0281-7

DOI

http://dx.doi.org/10.1186/s40360-018-0281-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111158443

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30611293


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