The effect of sonidegib (LDE225) on the pharmacokinetics of bupropion and warfarin in patients with advanced solid tumours.
CYP450 probes
bupropion
sonidegib
warfarin
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
16
03
2020
revised:
16
07
2020
accepted:
18
07
2020
pubmed:
1
8
2020
medline:
27
7
2021
entrez:
1
8
2020
Statut:
ppublish
Résumé
We evaluated the potential effect of sonidegib at an oral dose of 800 mg once daily (QD) on the pharmacokinetics (PK) of the probe drugs warfarin (CYP2C9) and bupropion (CYP2B6). This was a multicentre, open-label study to evaluate the effect of sonidegib on the PK of the probe drugs warfarin and bupropion in patients with advanced solid tumours. Cohort 1 patients received a single warfarin 15-mg dose on Day 1 of the run-in period and on Cycle 2 Day 22 (C2D22) of sonidegib administration. Cohort 2 patients received a single bupropion 75-mg dose on Day 1 of run-in period and on C2D22 of sonidegib administration. Sonidegib 800 mg QD oral dosing began on Cycle 1 Day 1 of a 28-day cycle after the run-in period in both cohorts. The geometric means ratios [90% confidence interval] for (S)-warfarin with and without sonidegib were: area under the concentration-time curve from time 0 to infinity (AUC Sonidegib dosed orally at 800 mg QD (higher than the Food and Drug Administration-approved dose) did not impact the PK or pharmacodynamics of warfarin (CYP2C9 probe substrate) or the PK of bupropion (CYP2B6 probe substrate).
Substances chimiques
Biphenyl Compounds
0
Pyridines
0
Bupropion
01ZG3TPX31
sonidegib
0RLU3VTK5M
Warfarin
5Q7ZVV76EI
Banques de données
ClinicalTrials.gov
['NCT01769768']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1291-1302Subventions
Organisme : NCI Cancer Center Support Grant
ID : 5P30CA023108
Organisme : Novartis Pharma
Informations de copyright
© 2020 The British Pharmacological Society.
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