Panse · The AAPS journal 2025 · In vitro laboratory assay · n=?

Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions.

Cited 1 times in the scientific literature.

Level 5 - mechanism / opinion, no new human data

In vitro bench research using pooled human and animal liver fractions

PubMed 40087222 · doi:10.1208/s12248-025-01044-7 · record verified 2026-08-26

What was done

Researchers evaluated the in vitro hepatic metabolic kinetics and clearance of the Veech ketone mono-ester ((R)-3-hydroxybutyl(R)-3-hydroxybutyrate, KE), its metabolite (R)-1,3-butanediol ((R)-1,3-BD), and the intermediate aldol. Kinetic parameters were measured using pooled human (mixed gender) and pooled rat (male and female) liver fractions.

What was found

KE exhibited rapid, non-saturable clearance in both human and rat liver fractions at concentrations up to 15,000 µM. Aldol also showed rapid, non-saturable hepatic clearance in human liver fractions. Conversely, (R)-1,3-BD demonstrated saturable metabolism with Km and Vmax values of 8,000 µM and 27.1 nmol/min/mg protein in humans, 19,300 µM and 113.5 nmol/min/mg protein in male rats, and 11,910 µM and 75.8 nmol/min/mg protein in female rats.

Why it matters

This study provides specific kinetic parameters for exogenous ketone ester metabolism, showing that while the parent ester and aldol intermediate clear non-saturably, hepatic metabolism of (R)-1,3-butanediol is capacity-limited in humans.

Limits

This is an in vitro assay utilizing pooled liver fractions; it does not measure in vivo pharmacokinetics, systemic tolerability, extrahepatic metabolism, or clinical outcomes in living human participants.

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