Effect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects

• Published in: European journal of clinical pharmacology Vol. 75; no. 8; pp. 1099 - 1108
• Main Authors: Dai, David, Yang, Hua, Nabhan, Salah, Liu, Hua, Hickman, Denice, Liu, Guowen, Zacher, Jeffrey, Vutikullird, Apinya, Prakash, Chandra, Agresta, Samuel, Bowden, Chris, Fan, Bin
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.08.2019; Springer Nature B.V
• Subjects: Administration, Oral; Adult; Antifungal agents; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - pharmacokinetics; Area Under Curve; Asian Continental Ancestry Group; Biomedical and Life Sciences; Biomedicine; Clinical trials; Cross-Over Studies; Cytochrome P-450 CYP3A Inhibitors - pharmacology; Dehydrogenases; Dose-Response Relationship, Drug; Drug dosages; Drug Interactions - ethnology; Ethnicity; FDA approval; Female; Food; Food-Drug Interactions - ethnology; Gene expression; Glycine - administration & dosage; Glycine - adverse effects; Glycine - analogs & derivatives; Glycine - pharmacokinetics; Healthy Volunteers; Humans; Itraconazole; Itraconazole - administration & dosage; Itraconazole - pharmacology; Leukemia, Myeloid, Acute - drug therapy; Long QT Syndrome - diagnosis; Long QT Syndrome - epidemiology; Long QT Syndrome - etiology; Male; Metabolism; Middle Aged; Minority & ethnic groups; Mutation; Patients; Pharmaceuticals; Pharmacokinetics; Pharmacokinetics and Disposition; Pharmacology/Toxicology; Pyridines - administration & dosage; Pyridines - adverse effects; Pyridines - pharmacokinetics; Isocitrate dehydrogenase 1 inhibitor; CYP3A4 inhibitors; Drug interaction; Food effect; Pharmacokinetics; Ivosidenib

Purpose To assess the effect of ethnicity, food, and itraconazole (strong CYP3A4 inhibitor) on the pharmacokinetics of ivosidenib after single oral doses in healthy subjects. Methods Three phase 1 open-label studies were performed. Study 1: Japanese and Caucasian subjects received single doses of 25...