A single-center, open-label study investigating the excretion balance, pharmacokinetics, metabolism, and absolute bioavailability of a single oral dose of [ 14 C]-labeled idasanutlin and an intravenous tracer dose of [ 13 C]-labeled idasanutlin in a single cohort of patients with solid tumors

Purpose Idasanutlin, a selective small-molecule MDM2 antagonist in phase 3 testing for refractory/relapsed AML, is a non-genotoxic p53 activator with oral administration. To determine the need to conduct dedicated trial(s) for organ impairment on pharmacokinetic (PK) exposure and/or drug–drug interactions, a single dose of [14C]- and [13C]-labeled idasanutlin was evaluated.