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David Pearson¹, Maxime Garnier¹, Alexandre Luneau²

¹a Pharmacokinetic Sciences , Novartis Institutes for BioMedical Research , Novartis Pharma AG , Basel , Switzerland.

Xenobiotica; the Fate of Foreign Compounds in Biological Systems

|September 15, 2018

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Leniolisib, a PI3K delta inhibitor, is primarily eliminated via metabolism, with drug-related material excreted in urine and feces. This study demonstrates effective mass balance determination without radiolabeling.

Area of Science:

Pharmacology
Drug Metabolism and Pharmacokinetics
Clinical Chemistry

Background:

Leniolisib is an investigational oral phosphatidylinositol-3-kinase (PI3K) delta inhibitor.
It is being developed for inflammatory and autoimmune diseases.

Purpose of the Study:

To investigate the absorption, metabolism, and excretion (ADME) of leniolisib.
To assess leniolisib's pharmacokinetic profile in healthy subjects following a single oral dose.

Main Methods:

A first-in-human clinical study involving a single 400 mg oral dose of leniolisib.
Quantification of parent drug and metabolites in plasma, urine, and feces using 19F-NMR and liquid chromatography.
Structure determination of metabolites via liquid chromatography coupled to tandem mass spectrometry.

Keywords:

CDZ173 Leniolisib fluorine NMR human ADME metabolite identification phosphatidylinositol-3-kinase (PI3K) delta inhibitor

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Main Results:

Drug-related material was predominantly excreted as oxidative metabolites in urine and feces, indicating metabolism as the primary elimination pathway.
No single metabolite was found to be abundant in plasma relative to the parent drug.
An average mass balance of 66% was achieved, showcasing the utility of 19F-NMR for ADME studies.

Conclusions:

Elimination of leniolisib occurs mainly through metabolism.
19F-NMR provides a viable method for obtaining extensive elimination and excretion data in early-phase clinical studies without the need for radiolabeled compounds.