European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Aug 2019
Randomized Controlled TrialEffect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects.
To assess the effect of ethnicity, food, and itraconazole (strong CYP3A4 inhibitor) on the pharmacokinetics of ivosidenib after single oral doses in healthy subjects. ⋯ No ivosidenib dose adjustment is deemed necessary for Japanese subjects. High-fat meals should be avoided when ivosidenib is taken with food. When co-administered with strong CYP3A4 inhibitors, monitoring for QT interval prolongation (a previously defined adverse event of interest) is recommended and an ivosidenib dose interruption or reduction may be considered. CLINICALTRIALS.GOV : NCT03071770, NCT02579707, and NCT02831972.