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Absorption, Distribution, Metabolism, and Excretion of [14C]BS1801, a Selenium-Containing Drug Candidate, in Rats.

Cheng Yang1,2, Mingzhen Xue3, Yifei He2

  • 1School of Chinese Materia Medica, Nanjing University of Chinese Medicine, Nanjing 210023, China.

Molecules (Basel, Switzerland)
|December 23, 2023
PubMed
Summary

This study investigated the metabolism of BS1801, a selenium-containing drug candidate for fibrosis. BS1801 was primarily excreted unchanged in feces, with identified metabolites including BS1801-M484.

Keywords:
BS1801 (butaselen)[14C]BS1801mass balancemetabolismseleniumtissue distribution

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Area of Science:

  • Pharmacology and Toxicology
  • Drug Metabolism and Pharmacokinetics

Background:

  • BS1801 is a selenium-containing drug candidate with potential therapeutic applications for liver and lung fibrosis.
  • Understanding the biotransformation and excretion of BS1801 is crucial for preclinical development and human mass balance studies.

Purpose of the Study:

  • To elucidate the metabolism, mass balance, and tissue distribution of BS1801 in rats.
  • To identify key metabolites and metabolic pathways of BS1801.

Main Methods:

  • Radiolabeling techniques ([14C]BS1801) were employed to track the drug in Sprague-Dawley/Long-Evans rats following a single oral dose.
  • Mass balance, tissue distribution, and metabolite identification were performed in plasma, urine, feces, and bile.

Main Results:

  • Over 93% of the radioactive dose was recovered within 168 hours, with feces being the primary route of excretion (<1% in urine or bile).
  • BS1801-related components were widely distributed in tissues. Fifteen metabolites were identified, with BS1801 detected only in feces.
  • BS1801-M484, a methylation product, was the most abundant plasma component. Major metabolic pathways included reduction, amide hydrolysis, oxidation, and methylation.

Conclusions:

  • BS1801 is primarily excreted as the intact drug via feces in rats.
  • The main metabolic pathways involve reduction, hydrolysis, oxidation, and methylation, leading to various identified metabolites.
  • No significant sex-based differences were observed in the distribution, metabolism, or excretion of BS1801.