Effects of Cytochrome P450 3A4 Inhibitors-Ketoconazole and Erythromycin-on Bitopertin Pharmacokinetics and Comparison with Physiologically Based Modelling Predictions.

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Abstract

To assess the effect of strong and moderate cytochrome P450 (CYP) 3A4 inhibition on exposure of bitopertin, a glycine reuptake inhibitor primarily metabolized by CYP3A4, and to compare the results with predictions based on physiologically based pharmacokinetic (PBPK) modelling.

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Journal

Journal ID (iso-abbrev): Clin Pharmacokinet

Title: Clinical pharmacokinetics

Publisher: Springer Nature America, Inc

ISSN (Electronic): 1179-1926

ISSN (Print): 0312-5963

Publication date (Electronic): Feb 2016

Volume: 55

Issue: 2

Affiliations

[1 ] Clinical Pharmacology, Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Hochstrasse 16, 4070, Basel, Switzerland.

[2 ] Pharmaceutical Sciences, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.

[3 ] Metabolism and Pharmacokinetics, Novartis Institute for BioMedical Research, Cambridge, MA, USA.

[4 ] Biostatistics, Product Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.

[5 ] Clinical Pharmacology, Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Hochstrasse 16, 4070, Basel, Switzerland. meret.martin-facklam@roche.com.

Article

Publisher Item ID: 10.1007/s40262-015-0312-0

DOI: 10.1007/s40262-015-0312-0

PubMed ID: 26341813

SO-VID: 1406caee-1d88-4c06-b27a-4094e2cff05c

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