The dual orexin receptor antagonist daridorexant does not affect the pharmacokinetics of the BCRP substrate rosuvastatin.
BCRP
daridorexant
drug-drug interaction
dual orexin receptor antagonist
pharmacokinetics
rosuvastatin
Journal
Clinical and experimental pharmacology & physiology
ISSN: 1440-1681
Titre abrégé: Clin Exp Pharmacol Physiol
Pays: Australia
ID NLM: 0425076
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
07
04
2020
revised:
10
06
2020
accepted:
19
06
2020
pubmed:
1
7
2020
medline:
12
11
2021
entrez:
1
7
2020
Statut:
ppublish
Résumé
Daridorexant is a dual orexin receptor antagonist in clinical development for the treatment of insomnia. Breast-cancer resistant protein (BCRP) is an efflux pump expressed in intestinal epithelium and hepatocytes, contributing to the absorption, distribution, and elimination of drugs and endogenous compounds. In vitro, daridorexant inhibits BCRP with an IC
Identifiants
pubmed: 32603512
doi: 10.1111/1440-1681.13370
doi:
Substances chimiques
Imidazoles
0
Pyrrolidines
0
daridorexant
0
Rosuvastatin Calcium
83MVU38M7Q
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1843-1849Informations de copyright
© 2020 John Wiley & Sons Australia, Ltd.
Références
Sakurai T, Amemiya A, Ishii M, et al. Orexins and orexin receptors: a family of hypothalamic neuropeptides and G protein-coupled receptors that regulate feeding behavior. Cell. 1998;92:573-585.
Sakurai T. The neural circuit of orexin (hypocretin): maintaining sleep and wakefulness. Nat Rev Neurosci. 2007;8:171-181.
Muehlan C, Heuberger J, Juif PE, et al. Accelerated development of the dual orexin receptor antagonist ACT-541468: integration of a microtracer in a first-in-human study. Clin Pharmacol Ther. 2018;104:1022-1029.
Dauvilliers Y, Zammit G, Fietze I, et al. Daridorexant, a new dual orexin receptor antagonist to treat insomnia disorder. Ann Neurol. 2020;87:347-356.
Treiber A, De Kanter R, Roch C, et al. The use of physiology-based pharmacokinetic and pharmacodynamic modeling in the discovery of the dual orexin receptor antagonist ACT-541468. J Pharmacol Exp Ther. 2017;362:489-503.
Muehlan C, Brooks S, Zuiker R, et al. Multiple-dose clinical pharmacology of ACT-541468, a novel dual orexin receptor antagonist, following repeated-dose morning and evening administration. Eur Neuropsychopharmacol. 2019;29:847-857.
Boof ML, Alatrach A, Ufer M, et al. Interaction potential of the dual orexin receptor antagonist ACT-541468 with CYP3A4 and food: results from two interaction studies. Eur J Clin Pharmacol. 2019;75:195-205.
Muehlan C, Zuiker R, Peeters P, et al. Pharmacokinetics and pharmacodynamics of the dual orexin receptor antagonist daridorexant in Japanese and caucasian subjects. J Clin Psychopharmacol. 2020;40:157-166.
Zammit G, Dauvilliers Y, Pain S, et al. Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder. Neurology. 2020;94(21):e2222-e2232.
Mao Q, Unadkat JD. Role of the breast cancer resistance protein (BCRP/ABCG2) in drug transport-an update. AAPS J. 2015;17:65-82.
Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry | FDA, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter-mediated-drug-interactions. Accessed February 24, 2020).
Crestor 10 mg film-coated tablets - Summary of Product Characteristics (SmPC) - (emc), https://www.medicines.org.uk/emc/product/7559/smpc. Accessed February 6, 2020.
Martin PD, Warwick MJ, Dane AL, et al. Metabolism, excretion, and pharmacokinetics of rosuvastatin in healthy adult male volunteers. Clin Ther. 2003;25:2822-2835.
Cooper KJ, Martin PD, Dane AL, et al. The effect of fluconazole on the pharmacokinetics of rosuvastatin. Eur J Clin Pharmacol. 2002;58:527-531.
Pan Y, Hsu V, Grimstein M, et al. The application of physiologically based pharmacokinetic modeling to predict the role of drug transporters: scientific and regulatory perspectives. J Clin Pharmacol. 2016;S122-S131.
Giacomini KM, Huang SM, Tweedie DJ, et al. Membrane transporters in drug development. Nat Rev Drug Discovery. 2010;9:215-236.
Özdemir V, Kalow W, Tang BK, et al. Evaluation of the genetic component of variability in CYP3A4 activity: a repeated drug administration method. Pharmacogenetics. 2000;10:373-388.
Sturzenegger C, Baumann CR, Lammers GJ, et al. Swiss narcolepsy scale. Clin Transl Neurosci. 2018;2:1-5.
Martin P, Gillen M, Ritter J, et al. Effects of fostamatinib on the pharmacokinetics of oral contraceptive, warfarin, and the statins rosuvastatin and simvastatin: results from phase I clinical studies. Drugs R D. 2016;16:93-107.