A Physiologically Based Pharmacokinetic Model of Ketoconazole and Its Metabolites as Drug-Drug Interaction Perpetrators.

P-glycoprotein (P-gp) cytochrome P450 3A4 (CYP3A4) drug–drug interaction drug–food interaction ketoconazole metabolites physiologically based pharmacokinetic (PBPK) modeling reversible inhibition

Journal

Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003

Informations de publication

Date de publication:
17 Feb 2023
Historique:
received: 23 12 2022
revised: 06 02 2023
accepted: 13 02 2023
entrez: 25 2 2023
pubmed: 26 2 2023
medline: 26 2 2023
Statut: epublish

Résumé

The antifungal ketoconazole, which is mainly used for dermal infections and treatment of Cushing's syndrome, is prone to drug-food interactions (DFIs) and is well known for its strong drug-drug interaction (DDI) potential. Some of ketoconazole's potent inhibitory activity can be attributed to its metabolites that predominantly accumulate in the liver. This work aimed to develop a whole-body physiologically based pharmacokinetic (PBPK) model of ketoconazole and its metabolites for fasted and fed states and to investigate the impact of ketoconazole's metabolites on its DDI potential. The parent-metabolites model was developed with PK-Sim

Identifiants

pubmed: 36840001
pii: pharmaceutics15020679
doi: 10.3390/pharmaceutics15020679
pmc: PMC9965990
pii:
doi:

Types de publication

Journal Article

Langues

eng

Subventions

Organisme : Federal Ministry of Education and Research
ID : 031L0161C
Organisme : Federal Ministry of Education and Research
ID : 031L0188D
Organisme : European Commission Horizon 2020 UPGx
ID : 668353
Organisme : Deutsche Forschungsgemeinschaft
ID : EXC 2180-390900677

Références

Clin Pharmacokinet. 1988 Jan;14(1):13-34
pubmed: 3280211
Biochem Pharmacol. 2016 Sep 15;116:153-61
pubmed: 27422753
Antimicrob Agents Chemother. 1982 May;21(5):730-3
pubmed: 6285814
J Med Chem. 2003 Apr 24;46(9):1716-25
pubmed: 12699389
Clin Ther. 2009 Feb;31(2):286-98
pubmed: 19302901
Ann Intern Med. 1983 Feb;98(2):160-7
pubmed: 6297345
Eur J Clin Pharmacol. 1987;33(5):531-4
pubmed: 3428348
Drug Metab Dispos. 2010 Jun;38(6):923-9
pubmed: 20304965
Clin Pharmacol Ther. 1999 Nov;66(5):461-71
pubmed: 10579473
J Pharm Sci. 2006 Jun;95(6):1238-57
pubmed: 16639716
Eur J Pharm Sci. 2022 Feb 1;169:106076
pubmed: 34856349
Biopharm Drug Dispos. 2017 Apr;38(3):260-270
pubmed: 28004396
J Pharm Pharmacol. 2011 Feb;63(2):214-21
pubmed: 21235585
CPT Pharmacometrics Syst Pharmacol. 2020 Jun;9(6):322-331
pubmed: 32543786
Scand J Clin Lab Invest. 2007;67(2):123-34
pubmed: 17365992
Drug Metab Dispos. 2011 Feb;39(2):170-3
pubmed: 21036951
Dig Dis Sci. 1987 Dec;32(12):1337-44
pubmed: 3691274
Drug Metab Lett. 2009 Aug;3(3):191-8
pubmed: 19799546
Expert Opin Drug Metab Toxicol. 2021 Nov;17(11):1293-1310
pubmed: 34727800
Pharmacotherapy. 1999 Dec;19(12):1378-84
pubmed: 10600086
Eur J Clin Pharmacol. 2000 Jun;56(3):259-61
pubmed: 10952482
Drugs. 1982 Jan-Feb;23(1-2):1-36
pubmed: 6276122
Int J Mol Sci. 2017 Mar 13;18(3):
pubmed: 28335386
Clin Pharmacol Ther. 1994 May;55(5):481-5
pubmed: 8181191
J Pharmacokinet Biopharm. 1994 Oct;22(5):327-65
pubmed: 7791036
Drug Dev Ind Pharm. 2007 Jul;33(7):755-65
pubmed: 17654024
Drug Dev Ind Pharm. 2015;41(10):1647-54
pubmed: 26288994
Drug Metab Dispos. 2004 Oct;32(10):1121-31
pubmed: 15242978
J Clin Endocrinol Metab. 2014 May;99(5):1623-30
pubmed: 24471573
CPT Pharmacometrics Syst Pharmacol. 2018 Oct;7(10):647-659
pubmed: 30091221
Eur J Drug Metab Pharmacokinet. 2016 Feb;41(1):45-54
pubmed: 25374256
J Pharm Sci. 2016 Sep;105(9):2712-2722
pubmed: 26921120
J Pharm Sci. 2004 Jun;93(6):1628-40
pubmed: 15124219
Br J Clin Pharmacol. 2012 Mar;73(3):411-21
pubmed: 21883386
CPT Pharmacometrics Syst Pharmacol. 2019 Dec;8(12):878-882
pubmed: 31671256
Drug Metab Dispos. 1997 Jun;25(6):772-7
pubmed: 9193882
Br J Clin Pharmacol. 1998 Nov;46 Suppl 1:30-4
pubmed: 9839763
Clin Pharmacol Ther. 1998 Sep;64(3):237-47
pubmed: 9757147
J Antimicrob Chemother. 1983 Aug;12(2):185-8
pubmed: 6311786
Antimicrob Agents Chemother. 1984 Jan;25(1):1-3
pubmed: 6322675
Clin Pharmacol Ther. 2011 Apr;89(4):562-70
pubmed: 21346758
J Antimicrob Chemother. 1981 Oct;8(4):299-304
pubmed: 6271723
J Clin Pharmacol. 1986 Nov-Dec;26(8):628-32
pubmed: 3793955

Auteurs

Fatima Zahra Marok (FZ)

Clinical Pharmacy, Saarland University, 66123 Saarbruecken, Germany.

Jan-Georg Wojtyniak (JG)

Clinical Pharmacy, Saarland University, 66123 Saarbruecken, Germany.
Dr. Margarete Fischer-Bosch-Institut of Clinical Pharmacology, 70376 Stuttgart, Germany.

Laura Maria Fuhr (LM)

Clinical Pharmacy, Saarland University, 66123 Saarbruecken, Germany.

Dominik Selzer (D)

Clinical Pharmacy, Saarland University, 66123 Saarbruecken, Germany.

Matthias Schwab (M)

Dr. Margarete Fischer-Bosch-Institut of Clinical Pharmacology, 70376 Stuttgart, Germany.
Departments of Clinical Pharmacology, and of Biochemistry and Pharmacy, University Hospital Tuebingen, 72076 Tuebingen, Germany.
Cluster of Excellence iFIT (EXC2180) "Image-Guided and Functionally Instructed Tumor Therapies", University Tuebingen, 72076 Tuebingen, Germany.

Johanna Weiss (J)

Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, 72076 Tuebingen, Germany.
German Center for Infection Research (DZIF), Heidelberg Partner Site, 69120 Heidelberg, Germany.

Walter Emil Haefeli (WE)

Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, 72076 Tuebingen, Germany.
German Center for Infection Research (DZIF), Heidelberg Partner Site, 69120 Heidelberg, Germany.

Thorsten Lehr (T)

Clinical Pharmacy, Saarland University, 66123 Saarbruecken, Germany.

Classifications MeSH