The use of microtracers in food‐effect trials: An alternative study design for toxic drugs with long half‐lives exemplified by the case for alectinib

• DOI: 10.1111/cts.13647
• Publication Date: 2023-10-13T04:51:12Z
• Authors: L. T. van der Hei...; N. Steeghs; J. H. Beijnen; A. D. R. Huitema; T. P. C. Dorlo
• Keywords: Bioequivalence; Alectinib

Abstract The traditional design of food‐effect studies has a high patient burden for toxic drugs with long half‐lives (e.g., anticancer agents). Microtracers could be used to assess in patients without influencing their ongoing treatment. feasibility microtracer study during steady‐state the therapeutic drug was investigated an silico simulation alectinib as example relative half‐life. Microtracer pharmacokinetics were simulated based on previously published population pharmacokinetic model and estimation food covariate oral bioavailability (assuming 40% food‐effect). Power defined fraction clinical trials where significant ( p < 0.01) identified. proposed 10 treatment, blood samples collected within 24 h after administration assumed had power 99.9%. mean estimated 39.8% (80% confidence interval: 31.0%–48.6%). demonstrated. allowed minimal influence treatment reducing compared half‐lives.