A Phase 1, Open-Label Study to Evaluate the Effect of Food and Concomitant Itraconazole Administration on the Pharmacokinetics of AMG 986 in Healthy Subjects

Autor: Ashit Trivedi, Omar Mather, Silvia Vega, Shauna Hutton, Jennifer Hellawell, Edward Lee
Rok vydání: 2021
Předmět:
Zdroj: Clinical pharmacology in drug developmentReferences. 11(7)
ISSN: 2160-7648
Popis: This phase 1, open-label study evaluated the effect of food and administration of the cytochrome P450 3A4 and P-glycoprotein inhibitor itraconazole (ITZ) on the pharmacokinetics of AMG 986. In cohort 1, 12 healthy subjects received a single oral dose of AMG 986 200 mg ± food on days 1 and 10. In cohort 2, 15 healthy subjects received oral ITZ 200 mg once daily on days 8 to 15 and a single oral dose of AMG 986 10 mg on days 1 and 11. The geometric least squares mean ratios of fed/fasted for AMG 986 maximum observed concentration (C
Databáze: OpenAIRE