Pharmacokinetic assessment
BLOOD
Blood samples were collected for PK assessment before the first dose and at 1, 2, 3, 6, and 8 h after oral milademetan on days 1 and 14 of cycle 1, before the dose on days 2 and 8 of cycle 1, and before the dose and at 3 h after milademetan on day 1 of cycle 2. Milademetan concentrations were determined using a validated HPLC/MS method. The lower limit of quantification was 0.500 ng/mL. Noncompartmental analysis was used to calculate the PK parameters from milademetan plasma concentrations. In addition, the Phoenix WinNonlin 8.1 software (Certara, Princeton, NJ, USA) was used for PK analysis.