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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
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- van Der Heijden, L. T. (author)
- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek The Netherlands Canc Inst, Div Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek Canc Inst, Dept Pharm & Pharmacol, Div Pharmacol, Plesmanlaan 121, NL-1066 CX Amsterdam, Netherlands.
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- Steeghs, N. (author)
- Netherlands Canc Inst, Antoni Van Leeuwenhoek Hosp, Dept Clin Pharmacol, Div Med Oncol, Amsterdam, Netherlands.
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- Beijnen, J. H. (author)
- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek The Netherlands Canc Inst, Div Pharmacol, Amsterdam, Netherlands.;Univ Utrecht, Fac Sci, Dept Pharmaceut Sci, Div Pharmaco epidemiol & Clin Pharmacol, Utrecht, Netherlands.
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- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands;Antoni Van Leeuwenhoek The Netherlands Canc Inst, Div Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek Canc Inst, Dept Pharm & Pharmacol, Div Pharmacol, Plesmanlaan 121, NL-1066 CX Amsterdam, Netherlands. Netherlands Canc Inst, Antoni Van Leeuwenhoek Hosp, Dept Clin Pharmacol, Div Med Oncol, Amsterdam, Netherlands. (creator_code:org_t)
- John Wiley & Sons, 2023
- 2023
- English.
- In: Clinical and Translational Science. - : John Wiley & Sons. - 1752-8054 .- 1752-8062. ; 16:12, s. 2557-2564
- Journal article (peer-reviewed)
Abstract
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- 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 food-effect in patients without influencing their ongoing treatment. The feasibility of a microtracer food-effect study during steady-state of the therapeutic drug was investigated in an in silico simulation study with alectinib as an example for a relative toxic drug with a long half-life. Microtracer pharmacokinetics were simulated based on a previously published population pharmacokinetic model and used for estimation of a model with and a model without food as a covariate on oral bioavailability of alectinib (assuming a 40% food-effect). Power was defined as the fraction of clinical trials where a significant (p < 0.01) food-effect was identified. The proposed study design of 10 patients on steady-state treatment, 10 blood samples collected within 24 h after administration and an assumed food-effect of 40% had a power of 99.9%. The mean estimated food-effect was 39.8% (80% confidence interval: 31.0%-48.6%). The feasibility of microtracer food-effect studies was demonstrated. The design of the microtracer food-effect study allowed estimation of the food-effect with minimal influence on therapeutic treatment and reducing patient burden compared to the traditional study design for toxic drugs with long half-lives.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
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