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A population pharmacokinetic (PK) analysis was conducted to characterize sources of interpatient variability on the PK of TAK-931, a cell division cycle 7 kinase inhibitor, in adult patients with advanced solid tumors using data from 198 patients who received oral TAK-931 over the range of 30 to 150 mg once daily in multiple dosing schedules in 2 phase 1 and 1 phase 2 clinical studies. A 2-compartment model with 2 transit compartments describing the absorption and first-order linear elimination adequately described the PK of TAK-931. The apparent oral clearance (CL/F) of TAK-931 was estimated to be 38 L/h, and the terminal half-life was estimated to be approximately 6 hours. Creatinine clearance (CrCL) was identified as a covariate on CL/F, and body weight as a covariate on CL/F, apparent central volume of distribution, and apparent intercompartmental clearance. Simulations using the final model indicated that the effect of CrCL (≥35 mL/min) or body weight (29.8-127 kg) on TAK-931 systemic exposures was not considered clinically meaningful, suggesting that no dose adjustments were necessary to account for body weight or renal function (CrCL ≥35 mL/min). Sex, age (36-88 years), race, and mild hepatic impairment had no impact on the CL/F of TAK-931. Taken together, the population PK analysis supports the same starting dose of TAK-931 in Asian and Western cancer patients in a global setting. © 2021 Millennium Pharmaceuticals, Inc. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.


Xiaofei Zhou, Aziz Ouerdani, Paul Matthias Diderichsen, Neeraj Gupta. Population Pharmacokinetics of TAK-931, a Cell Division Cycle 7 Kinase Inhibitor, in Patients With Advanced Solid Tumors. Journal of clinical pharmacology. 2022 Mar;62(3):422-433

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PMID: 34564871

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